Comparing the Two Main Prescription Drug Pricing Reduction Proposals

It seems like the Senate may—if Majority Leader Mitch McConnell (R-KY) does his job—be able to debate and vote on the Prescription Drug Pricing Reduction Act (PDPRA) of 2019 this Fall.

Not to be confused with the Prescription Drug Price Relief Act of 2019, which was introduced by Senator Bernie Sanders (D-VT), in January (and which gained little support), the PDPRA was a bipartisan piece of legislation, sponsored by Senate Finance Committee Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR). The full text is not yet available; PDPRA was created as a chairman’s mark, and has not been formally introduced (or available on the Congress.gov site). Interestingly, the bill was able to fend off attempts by other Republican members, notably by Senator Pat Toomey (R-PA), to defang it through the amendment process. On July 25, 2019, the proposal was passed by the Senate Finance Committee, with several reimbursement-based methods for improving utilization of biosimilars. This includes boosting the add-on payments for new biosimilars.

On September 19, 2019, Speaker Nancy Pelosi (D-CA) introduced the long-awaited House of Representative’s proposal (in outline form). The two bills contain several of the same provisions (see the Table) and may well set up a consensus around the final legislation, if passed in both chambers. However, the House bill does not offer incentives for increasing biosimilar uptake.

TABLE: Summary of Main Provisions of Drug Price Reduction Proposals

  PDPRA Speaker Pelosi’s Proposal*
Breadth Medicare only Medicare and Commercial
Use Medicare International Price Index? Yes Yes, as maximum negotiated price
Negotiated Drug Prices No Applies to up to 250 drugs (min, 25) that lack competition (including insulins); refusal to negotiate incurs penalties up to95% of previous year’s gross sales of drug
Penalties for Price Increases Above Inflation Retroactive rebate on Part B drugs (not biosimilars) that have raised prices above inflation, beginning January 2021; mandatory rebates on branded Part D drugs with price increaseshigher than inflation Retroactive rebate on all Medicare Part B and D drugs that have raised prices above inflation since 2016
Limits on Medicare Pharmaceutical Cost Sharing $3,100 Out-of-pocket limit on drug costs for Medicare beneficiaries $2,000 Out-of-pocket limit on drug costs for Medicare beneficiaries
Biologic Reimbursement Establish a WAC add-on payment of up to ASP + 3% when ASP has not yet been established; biosimilars would be paid the lesser of WAC + 3% or ASP + 6% of the reference product No provisions
Biosimilar Incentives Add-on payment for Part B biosimilars would now be ASP + 8% for first 5 years of sale No provisions
Other Significant Provisions Exclude patient assistance coupon value from Medicare ASPcalculations Not addressed
  Require drugmakers withoutMedicaid drug rebate agreements to report quarterly ASPs to HHS, on which reimbursements will be based Not addressed
  Require refunds be paid to HHS on any single-dose vial Part B drugs for unused amounts that exceed a threshold Not addressed
  Maximum ASP plus add-on payment that a provider may receive per year administering one drug is $1,000 Not addressed
  Website publication of aggregate price concessions (including rebates and discounts) on Part D drugs Not addressed
  Require manufacturer justification (publicly posted) for price increases based on certain minimums and thresholds Not addressed
*Based on Proposal Outline, as of Sept 19, 2019.

Although President Trump has indicated support for the overall theme of drug pricing reduction, he has not endorsed either bill or its specific combination of actions. The Republican opposition to the Senate’s PDPRA is likely to be heavy, and Senate GOP opposition to Speaker Pelosi’s bill will also be a difficult barrier, even without the President’s support.

If both bills can make it to the conference stage, the Administration may be able to claim that it has delivered on one of its campaign promises. Otherwise, the drug pricing reduction proposals will result in another dead end, similar to the drug rebate safe harbor appeal and drug patent reform.

How Confusing Is Biologic and Biosimilar Substitution?

Evidence is mounting, especially from Europe that biosimilars to a single reference product result in the same clinical outcomes, with no appreciable safety issues. Evidence of this type from America will take time to accumulate, because competition in categories with multiple biosimilar options has been much more limited.

British Columbia biosimilar uptake

The recent announcement in British Columbia of the province’s decision to switch patients with inflammatory bowel disease from Remicade® to biosimilars has once again inflamed some passions. This is part of a broader effort by the Canadian province to increase utilization of biosimilars to gain economic savings. The Canadian GI Society, an advocacy group, published a letter firmly against the plan. They believe only the physician and patient should decide whether a biosimilar switch should occur. The British Columbia government, on the other hand, will pay for either Renflexis® or Inflectra® but not Remicade® after March 5, 2020. Even if patients have been taking the reference product, they will have to switch to one biosimilar or the other.

The Biosimilar Switching Argument

With medical experience supporting the case for switching, the argument by this Canadian advocacy group is less than solid. There may be the need for a medical exception for the infrequent patient taking infliximab, but these drugs can be effectively switched: there is no meaningful difference in effectiveness and safety outcomes on a population-wide basis among infliximab choices.

That said, here is where the supporting arguments get somewhat messy. The Food and Drug Administration (FDA) approves a biosimilar based on its equivalence to a reference product (not to other biosimilars). At the implementation of the Biologics Price Competition and Innovation Act, a biosimilar manufacturer has been required to show that its biosimilar was comparable in physiochemical, pharmacokinetic, and clinical studies to a designated reference product (i.e., US-licensed version of the originator). That required some manufacturers to first prove the equivalence of the US-licensed version to the EU-approved originator in a “bridging study.” This requirement was borne from the understanding that the US- and EU-licensed originator biologics make not be exactly the same either—biosimilars of each other. With more experience, the FDA has backed away from this requirement, understanding that the clinical outcomes differences between two licensed originator products are negligible.

The Laws of Transitivity and Biosimilar Switching

However, the FDA has not revised its opinion on whether two drugs proved to be biosimilar to one reference product are biosimilar to each other. Nor whether an interchangeable biosimilar might be considered interchangeable with other biosimilars. The answer remains: The evaluation process does not require such testing to gain basic biosimilar approval. In other words, the evidence did not yet exist.

This all relates to the basic premise of so-called “nonmedical substitution.” The issue is whether a payer-initiated change with a noninterchangeable biosimilar is considered to be more like therapeutic or generic substitution. Therapeutic interchange or substitution takes place when a drug is switched for another in the same category (e.g., switching Lipitor for a different statin rather than the generic atorvastatin).

Therapeutic Interchange vs. Biologic Substitution

A payer would be hard pressed to justify an unauthorized switch of adalimumab for infliximab. They are very different TNF-inhibitors. Patient outcomes would likely be affected in some way. Are Inflectra and Renflexis—different infliximab biosimilars—to be considered wholly different biologics? Because the FDA does not endorse that Inflectra and Renflexis are biosimilar to each other, it does imply (whether wrongly or rightly) that they are different biologic brands. If this was considered in the traditional sense, switching might be construed as an example of therapeutic interchange.

Framing the argument in this manner can drive patient and provider resistance to biosimilar uptake. Misinformation? Rather, I believe that this is an embodiment of the ambiguity of our regulatory policies. Certainly, payers don’t subscribe to it; they cover one versus another based more on net costs—certainly not on clinical outcome differences. For payers, it is more black and white; for certain other groups, much remains gray, especially when people believe more decision-making authority is being challenged. Only greater biosimilar clinical utilization, proof of savings, and better dissemination of education about this experience will change advocacy’s perspective .

Biocon and Mylan: The Race to Approve Insulin Glargine Follow-on

Biocon received a second complete response letter relating to manufacturing plant problems in Malaysia. This may seem like a straight forward issue that could hamper its efforts to produce an insulin glargine follow-on agent, but it can become a major problem barring a very quick resolution.

In the filing Biocon made to the India Stock Exchange, the company said, “The CRL did not identify any outstanding scientific issues with the application. We remain confident of the quality of our application and do not anticipate any impact of this CRL on the commercial launch timing of our insulin glargine in the US.” However, that may be a fairly optimistic opinion.

Insulin copies are part of the class of biologics designated “transitional products” that will be approved only through the 351(k) biosimilar approval pathway after March 2020. The latest rules issued by the Food and Drug Administration (FDA) specify that if a product in this drug class (and others like growth hormones) does not receive approval by this date, the manufacturer must submit an entirely new biologic licensing application (for approval as a full-fledged biosimilar). That would require completing all of the necessary developmental steps—proving the physiochemical and pharmacodynamic equivalence to what would now be termed the reference product—Lantus®.

The FDA rules for transition products do not exempt agents that have already received complete response letters and may still be in the FDA’s queue. This is relevant because neither of Biocon’s rejection letters (the first issued in June 2018) pointed to problems with the scientific evaluation of its insulin glargine. Rather, both involved failed inspections at the plants at which Biocon was going to manufacture the agent. The drug was approved by the European Medicines Agency and is currently available by prescription in the EU.

As indicated in a previous post, pharmaceutical company interest in insulin biosimilars is fairly low. That may be because of the approaching transition date.

The question remains, can Biocon correct its Malaysian manufacturing plant deficiencies, can FDA reinspect, and can FDA issue final approval for this 505(b)2 agent before February 29, 2020? If not, even if Biocon’s plant passes inspection in December 2019, that will likely result in years’ long delay before the new BLA can be submitted.

Do Skinny Labels for Biosimilars Matter to Payers?

Extrapolation of indications by the Food and Drug Administration (FDA) has been widely accepted by providers, payers, and most patient groups. Yet how to address the approval of a narrow indication list (or skinny label) seems less settled.

Skinny labels

The four FDA-approved adalimumab biosimilars received the agency’s endorsement for a large set of Humira®’s 10 indications. Amjevita® and its brethren were approved for the treatment of moderate-to-severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe Crohn’s disease in adults, plaque psoriasis, moderate-to-severe polyarticular juvenile idiopathic arthritis, and moderate-to-severe ulcerative colitis. Missing are indications to treat pediatric Crohn’s disease, hidradenitis suppurativa, and noninfectious uveitis (regardless of severity). When payers are asked whether these missing indications (especially involving other autoimmune disorders) are important for coverage decision making, they will likely agree that it makes little difference to them.

In perhaps the more important biosimilar example, rituximab, the indications are split between cancer treatment (e.g., non-Hodgkin’s lymphoma and chronic lymphocytic leukemia) and autoimmune therapy (e.g., rheumatoid arthritis, polyangiitis, pemphigus vulgaris). Although the dosing rate (50 mg/hr) is the same, Rituxan is given as part of a cytotoxic chemotherapy regimen for patients with non-Hodgkin’s cancer versus methotrexate and methylprednisone for autoimmune treatment. The two rituximab biosimilars (Truxima® and Ruxience®) approved by the FDA do not have the rheumatoid arthritis indication, although Ruxience has received approval for polyangiitis.

The reasons their manufacturers sought the skinny labels could be many, including avoidance of patent infringement, quicker path to FDA approval, or simply limited resources. However, Pfizer did complete a phase 3 trial in RA for Ruxience. Currently, Amgen/Allergan have completed phase 3 trials for both non-Hodgkin’s lymphoma and rheumatoid arthritis for their investigational biosimilar ABP 798. It is possible that the partners could submit a 351(k) biologic license application at the end of Q4 2019 or Q1 2020.

For payers, the presence of skinny labels for biosimilars versus approval for the entire set of indications matters little. In several market research projects we have conducted with managed care medical directors and pharmacy directors, their answers have been consistent: If the biosimilar is approved by the FDA and is covered by the health plan or insurer, then the payer will be far less concerned how the biosimilar is used. The reasons are simple: Payers are gaining comfort with biosimilar use. If the reference product and biosimilar have been demonstrated to be sufficiently equivalent to produce equivalent outcomes, and the biosimilar is less expensive, why overmanage its use?

Further support for this view was published this month in BioDrugs. These South Korean authors evaluated 11 head-to-head randomized, control trials of rituximab biosimilars for use either non-Hodgkins lymphoma or RA. A total of 3,163 patients were included in the meta-analysis. Response rates in the trials for lymphoma and RA were consistently equivalent, and no significant differences were revealed in the formation of antidrug antibodies. Perhaps the best opportunity for managed care organizations to restrict the use of a biosimilar (or biologic) outside of step therapy is the ubiquitous prior authorization (PA). Today, there is little, if no, reason for PA criteria to be different for a reference biologic or its biosimilar(s), other than price preference. In that case, the skinny label has little effect on a payer’s coverage.

Gottlieb: We Can Still Address Rebate Safe Harbors Through Congress

During his time as FDA Commissioner, Scott Gottlieb, MD, was an ardent proponent of the biosimilar industry. He, along with Health and Human Secretary Alex Azar, introduced several proposals to improve biosimilar access and competition for biologics in an effort to reduce the cost of these expensive complex molecules.

biosimilar naming
Scott Gottlieb, MD

Now, as a Resident Fellow of the American Enterprise Institute, Dr. Gottlieb is still pressing for a biosimilar-friendly environment. A column in the Wall Street Journal continues to advocate for several of the initiatives he introduced at FDA, including those comprising the Biosimilar Action Plan.

The proposal that may have caused the most disruption to the biologic status quo was the removal of the safe harbor for pharmaceutical rebate contracts. The safe harbor protected drug makers from the antikickback statute (section 1128B[b] of the Social Security Act) and helped proliferate rebate contracts between pharma and the payers, distributors, and health systems, usually in exchange for preferred positioning or even nonpreferred formulary coverage.

As discussed in this space in previous months, several stakeholders besides the biosimilar manufacturers (including payers) were heartened by the prospects for removal of the safe harbor. However, fears of rising Medicare premiums for beneficiaries pulled the plug on hopes for the repeal of the safe harbor.

Peter Bach, MD, at Mount Sinai Medical Center, New York, co-authored a recent commentary in the same newspaper, expounding on the belief that price controls on biologics beyond their marketing exclusivity term would be a more effective and efficient tool than biosimilars to save money for the health system. In response to this column, Dr. Gottlieb raised the notion that Congress could raise the safe harbor repeal from the dead.

“Among other dangers, this could trigger shortages of the drugs,” he wrote of Dr. Bach’s proposal. “It would also discourage investment in manufacturing.”

Dr. Gottlieb also pointed out that biosimilar development could be assisted by prohibiting biologic manufacturers from withholding samples of their agent from prospective biosimilar makers through either astronomical pricing or claiming that a REMS program prohibits this type of distribution. These actions would help encourage very early stage biosimilar development. They would do little to help encourage competition (and thus lower prices) once a biosimilar is approved, however.

On the other hand, if drug rebates were taken off the table, biosimilars and biologics would have to compete on list price and discounts solely, a move that would decisively even the playing field. It would also remove the heavy incentive payers currently have to maintain existing formulary coverage for reference biologics.

Barring the removal of the safe harbor and thus the rebate tool, biosimilar manufacturers would have nothing to convince payers to cover them other than tremendous price discounts. In a marketplace like that for the G-CSFs at present and the very crowded trastuzumab marketplace in the near future, this will inevitably mean a race to the bottom in pricing and withdrawal of some competitors. That will result in far less interest in developing biosimilars for newly expiring biologics.

The BBCIC Demonstrates Feasibility of Insulin Safety Monitoring in Types 1 and 2 Diabetes

New insulin products will transition to being categorized as full-fledged biosimilars in 2020. The Biologic and Biosimilar Collective Intelligence Consortium has just published the results of an evaluation to determine whether its research network could detect safety signals in long-acting and intermediate-acting insulins used to treat type 1 and type 2 diabetes.

biosimilar insulins

Published in the August 2019 Journal of Managed Care and Specialty Pharmacy, the BBCIC found that it could detect hypoglycemia and major adverse coronary events (MACEs) in a population of over 4,500 patients with type 1 diabetes and nearly 104,000 patients with type 2 diabetes who had taken insulin, based on available claims and health data. These proof-of-concept studies demonstrated the ability of the investigators to obtain data on insulin use (days supply and specific type of insulin, A1c levels, as well as adverse events).

The researchers found a similar incidence of hypoglycemia and MACE outcomes in patients with type 1 disease taking long-acting insulins compared with NPH insulins. In the type 2 study, they found that insulin was used for an average of 3.5 months, and patients had an average follow-up of 8.6 months, during the period of interest.

In the type 2 study, the BBCIC team found an unadjusted rate of severe hypoglycemic events of 96.9 per 10,000 patient-years at risk. The unadjusted incident MACE rate was 676.9 events per 10,000 patient-years. Over 38,000 of these patients had a baseline A1c level available among the records analyzed; fewer than 50% though had a follow-up A1c result entered into the records system.

Furthermore, in the type 2 study, the researchers were able to screen patients taking insulin in combination with (1) other insulin types as well as (2) second-generation sulfonylurea agents. Patients taking other medication combinations were not included in the data analysis.

Based on this work, BBCIC is confident that it will be able to conduct postmarketing surveillance on new innovator insulins as well as biosimilar insulins as they are introduced and tracked over time.

The BBCIC’s distributed research network can access 10 years of claims data covering approximately 100 million lives, including approximately 20 million active members in 2017 from 2 major US health plans and 3 regional integrated delivery networks. 

UHC Keeps Its Options Open: Amgen’s Trastuzumab and Bevacizumab Biosimilars Will Be Preferred Products in 2020

Likely focused on a best price policy, not a biosimilar-only policy, one of the largest national payers has announced that Amgen’s two new biosimilars to treat cancer will be accorded preferred formulary status over the reference agents. This formulary policy will be implemented January 1, 2020 for UnitedHealthcare’s (UHC’s) Medicaid and commercial plans (but not the company’s Medicare Advantage plan).

This action will also preclude other trastuzumab or bevacizumab biosimilars from obtaining preferred status at UHC once they are finally launched. This decision fuels Amgen’s business case for getting to the market first. No doubt, Amgen offered enticing discount and/or rebate incentives to achieve a lower net price than Roche currently offers.

One may also consider that Amgen obtained preferred status for Kanjinti® and Mvasi® as part of a portfolio or bundled contract. Amgen already has preferred status at UHC for its pegfilgrastim agent Neulasta® and the Onpro® on-body injector for Neulasta. With its currently available biosimilars and biologics for the oncology market, this strategy would make a lot of sense.  

However, UHC did specify in its policy update that Sandoz’s Zarxio® (filgrastim) is the initial step required before proceeding to the longer-acting form pegfilgrastim. Regardless of UHC’s preference for Neulasta, this indicates that Zarxio will have to be tried first, restricting access to a degree. This policy change also is effective for the commercial and Medicaid (also referred to as UHC Community Plans) plans but not the Medicare Advantage plans.

As outlined in an earlier post, UHC preferred the originator brand Remicade® over the biosimilars (Inflectra® and Renflexis®).

This also demonstrates the nature of the moving target of best net costs. Nothing prevents Roche from increasing rebates or discounts to try to win back the UHC business.

In related biosimilar news… Seema Verma, Administrator of the Centers for Medicare and Medicaid Services, has reiterated the administration’s support for the Medicare International Price Index (IPI) drug pricing demonstration project. This initiative has been delayed from an expected proposed rule release of this past spring. According to the report, she did not specify when the rule would be made public, but stated it was a “top priority for my department.”

Thirty Years of Exclusivity for Enbrel? It’s Time for Some Common Sense

No pharmaceutical drug is entitled to 30 years of unfettered marketing exclusivity. Let’s be straight about that up front. Regardless of results of the patent settlements or the results of inter partes review, this is just common sense for a market-based economy.

Ask anyone in the pharma industry, in the payer sector, or on the health systems side of the fence. I doubt that Amgen executives, the beneficiary of the US District Court’s ruling, believe that a drug launched in 1998 should be shielded from competition until 2029. After all, Amgen is also the company that just launched two cancer biosimilars, challenging Roche’s intention to protect Herceptin and Avastin’s exclusivities as long as it possibly can.

The ruling by the US District Court of New Jersey on August 8th, that Amgen’s patents on etanercept are valid, puts Sandoz into quite a quandary. It challenges a key provision of the Biologic Price Competition and Innovation Act (BPCIA) as well. This decision will likely cost Sandoz somewhere between $5 billion and $10 billion in lost US biosimilar etanercept sales over the next 10 years. Sandoz may have some business alternatives; its legal alternatives already being exercised: it has sought and will receive an expedited appeal through the US Court of Appeals.

Interestingly, Roche (which seems to be a party to so much action on the biosimilar front these days) was the first to file applications for these specific patents on etanercept. Immunex had obtained the rights to the patents, and it was subsequently purchased by Amgen.

Sandoz did not contest that it would infringe upon the patents, but the US District Court judge also found that Sandoz failed to prove that the patents should be considered invalid. The judge’s decision means that Sandoz’s work in developing Erelzi® for the US market may be for naught. For most of the past 3 years, Sandoz had the only approved etanercept biosimilar. Until very recently, when Samsung Bioepis obtained FDA approval for Eticovo®, the window of opportunity was all Sandoz’s.

Also, until very recently, it seemed that the Federal Trade Commission was going to serve as the competitive backstop for patent issues such as these. A reasonable person might expect the FTC to eventually set aside these patents, and open the market to biosimilar competition, simply on the basis that they are attempts to maintain market exclusivity well beyond the 12-year period provided by the BPCIA.

However, the Trump administration has backed away from that potential remedy. The District Court is not charged with ruling whether Amgen’s patents are anticompetitive, only whether it considers the patents to be valid. That being the case, arguing the Court’s decision here (based on whether the patents are obvious) is not a fruitful exercise.

This case, however, can serve as a renewal for the call to action by the FTC. One business remedy may be a settlement between Amgen and Sandoz, which allows the latter to market an authorized biosimilar, in exchange for a share of the profits. This does not affect Samsung Bioepis, which is fighting its own patent battle with Amgen over this reference product. The FTC has criticized “pay-for-delay” deals in general, and even if this was signed and implemented by January 1, 2020, the authorized biosimilar would almost certainly carry a higher WAC cost than a two-biosimilar launch scenario.

As a result, we are still awaiting some common sense here. The 12 years of exclusivity is written into the BPCIA statute. AbbVie’s Humira® will also have benefited from 20+ years of exclusivity when the first biosimilar is launched in 2023. Thirty years is a wholly unnecessary insult to the BPCIA and to the health system.

Tens of billions in projected health system savings from use of biosimilars is eroding heavily each year common sense is set aside. If I were a prospective biosimilar manufacturers, I would be seriously reconsidering the marketplace opportunities and where to spend my resources.

The FTC should intervene, and use some common sense guard rails in this unique balance of intellectual property and competition.

Momenta Drops Out of Biosimilar Adalimumab Competition

In reporting its second quarter earnings, Momenta Pharmaceuticals stated on August 2 that it no longer plans to market M923, its biosimilar version of Humira®.

“Today, Momenta announced the Company will cease active development of M923 at this time, due to changes in the market opportunity associated with Humira patent litigation settlements,” according to a company press release.

In 2018, Momenta decided to drastically scale back its biosimilar development as part of a strategic review. However, it continues to partner with Mylan on one remaining biosimilar candidate, M710. This is a biosimilar version of aflibercept (Eyela®).

Momenta’s troubles were first apparent after it completed its phase 3 trial of M923 in psoriasis. The clinical study pitted the biosimilar versus the EU-licensed version of adalimumab, and was successfully completed in 2017; however, no FDA filing ensued, despite a company announcement that it would occur in 2018. Later that year, the company stated that it delayed filing for financial reasons, but it would continue to seek a partner to commercialize the product.

In 2018, it signed a licensing agreement with AbbVie, which would have allowed it to launch in December 2023—in the back of the pack of licensed biosimilars in terms of timing (which could not have helped its efforts to seek a partner). In view of its refocusing its strategic outlook, the delay in filing a 351(k) biologic licensing application (BLA) application with the FDA may have made some sense from a couple of perspectives

First, the company may have thought twice about continuing expenditures if it was undecided as to whether it would remain committed to the biosimilar development. These expenditures could be quite significant (beyond payment of user fees) if the FDA requested additional data in an initial review of the BLA.

Second, with a potential launch date of December 2023, Momenta certainly had time to get its ducks in a row. If a commercialization partner could be lined up before the BLA filing, that company could help shoulder additional associated costs.

In any case, Momenta’s pull back is not entirely unexpected. Though it intended to file an application with the European Medicines Agency early this year (which would not have required a further delay in launch), this also did not occur (probably because of existing biosimilar adalimumab competition in Europe).

Momenta’s pipeline, beyond aflibercept, consists of other biologics for rare diseases. Its marketed products are for generics of Copaxone® and Lovenox®.

New Managed Care Pharmacy Survey Shows Broad Support for Biosimilar Adoption

According to a study published in the Journal of Managed Care and Specialty Pharmacy, managed care pharmacy executives are fully onboard with encouraging the use of biosimilars: Eighty-four percent agree that these FDA-approved agents are safe and effective for use in patients who are taking a reference product.

The researchers sent survey invitations to more than 10,000 members and contacts of the Academy of Managed Care Pharmacy. The survey, conducted in October 2018 was limited to the first 300 respondents. All potential pharmaceutical industry participants were excluded through the use of screening questions. Roughly two-thirds of those participating were pharmacy directors or clinical pharmacists.

The survey asked whether they believed certain policies would improve biosimilar uptake. The results indicated respondents’ belief that prescriber education was still a principal problem (Table). However, they also looked inward, as formulary policies and reduced patient cost sharing may also be key opportunities for improving uptake. Indeed, only 20% of those surveyed were working in health plans or insurers that have established preferences and policies to promote biosimilars over reference products. Eleven percent (at the time of the study) preferred biologics to biosimilars. This may have changed significantly, based on UnitedHealthcare’s recent moves to favor reference agents.

TABLE: LIKELIHOOD THAT SPECIFIC STRATEGIES CAN OVERCOME BARRIERS TO BIOSIMILAR UPTAKE

Strategy Extremely or Likely to Be Successful
Prescriber education on switching studies 91%
Clear FDA guidance on substitution 90%
Formulary policy for treatment-naïve patients 88%
Prescriber education on real-world studies 86%
Expanded Medicare/Medicaid policies 84%
Reduced patient cost sharing for biosimilars 80%
Formulary policies for switching 73%
Government-funded interchangeability studies 70%

When asked about how formidable these challenge were to overcome, 61% said that provider education was “extremely difficult” or “difficult” to overcome. The inevitable pricing and contracting issues were a close second, at 57%. Respondents offered that this was a competitive hurdle that biosimilar manufacturers must tackle—they need to be more aggressive at launch in terms of discounts off of retail prices and contracting. Concerns about biosimilar safety and efficacy among payers were the least worrisome, with only 23% rating this challenge difficult or extremely difficult.

Only 9 months ago, when the survey was conducted, the US biosimilar arena was far different. It took place after approval and launch of the first pegfilgrastim biosimilar but before the launch of the cancer-treating biosimilars. The discussion of rebate safe harbors was in full swing, the federal government was thinking through its approach to peeling back the patent thicket, and a war on drug pricing was being waged. Today, only the drug pricing efforts are still ongoing. Any hopes for an adalimumab biosimilar launch before 2023 have disappeared. However, a handful of critical launches (e.g., Udenyca®, Kanjinti®, Mvasi®) have pressed more immediate discussion of biosimilar uptake.

The results of this survey demonstrate once again that pharmacists working in managed care organizations are very open to helping spur biosimilar access. Both the manufacturers and payers need to take advantage of this opportunity today.