Asembia 2022: Legislation and Innovation for Specialty Pharmacy

Key takeaway: What’s most important

For continued specialty pharmacy growth, in both value and patient reach, supporting legislation and regulation are key, presenters said.

At the federal level, policies to keep an eye on are:

• The prescription-drug-pricing policy section of the Build Back Better Act, which includes out-of-pocket spending caps for Medicare part D beneficiaries. This could impact biopharma innovation, with greater development risks for drugs that target the Medicare population. White noted this could mean less incentive for developing novel therapies for conditions like Alzheimer’s, osteoporosis and arthritis.

• Part D Proposed Rule, which would prevent Part D sponsors from recouping increasing pharmacy price concession. CMS estimates these fees grew 107,400% between 2010 and 2020.^[2]DIR Fees Relief: Reducing Costs, Improving Health, NACDS, 2022

At the state level, policies to watch include:

• Varying real-time prescription benefit transparency (RTBT) bills and policies. Russell noted this is an example of states coming up with “50 different ways of doing things” due to inaction on the federal level.

• Value-based payment arrangements (VBPs), which make it easier for specialty pharmacies to be an involved part of the system. Under VBPs, specialty pharmacies could be an active participant with payers and manufacturers in care delivery and reporting outcomes measures. As a result, specialty pharmacy can play an integral role in these arrangements and their success in providing value to all players.

On a broad scale, policies that address data liquidity can help specialty pharmacists access information necessary to best help patients, including information on copay accumulators, benefit design and out-of-pocket cost.

Achieving industry interoperability and data transparency can also pave the way for improved medication access, affordability and adherence. For patients, presenters said, this means a greater likelihood for improved outcomes.

The industry call to action

Two-thirds of drug launches in the next five years are predicted to be specialty medications.^[3]The Global Use of Medicine in 2019 and Outlook to 2023, IQIVIA Institute, 2019 As specialty therapies grow, visibility across the care continuum — including at the specialty pharmacy — will be even more critical to improve medication access, patient care and workflows.

Legislators, activists and advocacy organizations can help specialty pharmacists by supporting policies that improve integrative workflows — not more one-off tools and tasks. This increased efficiency can help specialty pharmacists continue in elevated clinical roles, increase speed to therapy and deliver better patient care.

Session: “Specialty Pharmaceutical Pipeline Updates”

Presenter(s): Ray Tancredi, divisional VP, Specialty Pharmacy Development & Brand Rx/Vaccine Purchasing, Walgreens

Summary: What was discussed

This session discussed drugs in the FDA pipeline that could have the biggest impact for patients. The medications were broken down by rare and orphan, specialty, gene therapy and oncology.

Before moving through the drug pipeline, Tancredi addressed adjacent trends the drug pipeline is shaping in the specialty pharmacy industry. Among these trends was innovation focused on healthcare disparities and equity. The cost and access challenges associated with specialty drugs, he said, could widen the access gap for lower income and traditionally underserved populations. Other trends include the incoming wave of biosimilars in the pipeline, with the current top-selling drug in the United States potentially gaining one to six new biosimilars in the marketplace by 2023.

Tancredi also provided commentary on potential game-changing therapies, specific therapy areas that could be seeing larger pockets of innovation and what to look for in future approvals. Cell and gene therapies are standouts. He said the FDA expects to approve 10 to 20 cell and gene therapies annually by 2025.^[4]Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies, FDA, 2019

Key takeaway: What’s most important

The drug pipeline is showing huge promise for rare diseases, previously difficult-to-treat conditions and one-time therapies. Innovations in cell and gene therapy continue to push the boundaries of what’s possible in medicine, helping treat these diseases more effectively and providing opportunity for improved patient outcomes. This is especially important for rare or orphan diseases. Each affects 200,000 or fewer Americans each year, but with 7,000 known orphan diseases, about 30-million Americans are affected by one.^[5]Rare Disease Day: Frequently Asked Questions, Rare Diseases, 2019 Tancredi said the FDA is approving orphan and ultra-orphan more often than other products. There were 58 drugs approved in 2021, and he expects to see 48 to 58 approved this year as well.

The industry call to action

Pipeline drugs are often bellwethers for shifts in the healthcare industry. Regulation and reimbursement methods, care team approaches, patient education and administration all can change when novel therapies hit the market. They’re also hitting the market more quickly than in recent years. Many drugs for cancer — especially those Tancredi highlighted — were receiving fast-track and priority reviews, meaning they’re being approved in earlier stages of clinical trials.

Industry stakeholders may need transparency and data exchange more than ever. The end result could mean more patients can receive novel therapies that have proven clinical benefit and improved outcomes.

Session: “Digital Therapeutics Are Promising, So Why is Payer Uptake So Slow?”

Presenter: Jayne Hornug, chief clinical officer, pharmacy, Managed Markets Insight & Technology (MMIT)

Summary: What was discussed

One of 2022’s notable healthcare trends continuing to gain momentum are digital therapeutics. Digital therapeutics are evidence-based, clinically evaluated software and devices a provider can prescribe to help a patient manage a specific condition. They’re designed and tested much like traditional prescription drugs, but rather than a pill or injection, the patient receives therapy through software, an electronic device or a combination of both.

Despite many promising developments in digital therapeutics, including treatments for ADHD, payer willingness to include them on their formularies has been slow. This is partially due to the FDA lacking a true regulatory pathway for approving digital therapeutics. It could also be a fear of the unknown. With the COVID-19 pandemic accelerating digital healthcare, Hornug said the payer landscape needs to evolve to help patients access these innovative methods of care.

Hornug also shared key insights from the recent survey of pharmacy benefit managers (PBMs) and specialty pharmacy professionals by Managed Markets Insight & Technology (MMIT). \

Key takeaway: What’s most important

Payers are hesitant to cover digital therapeutics because there’s no precedent for them. Only 25% of payers surveyed had a contract in place with a digital therapeutic manufacturer. In the MMIT survey, payers largely agreed the most important attribute of a new prescription digital therapeutic is clinical outcomes.

Hornug said to move the needle, companies developing digital therapeutics have a responsibility to provide solid clinical evidence of patient outcomes and to find ways to reduce costs.

The industry call to action

There are potential payer management strategies under the pharmacy benefit that could improve the uptake of digital therapeutics — and provide access to those tools that could improve patient outcomes. This could be especially meaningful for patients with traditionally less access to healthcare due to social determinants of health. All players in the digital therapeutic space, including providers and patients, may need more education on when and how these treatments are best implemented for maximum patient benefit.