Spotlight on Market Access

To say that the FDA’s approval of Biogen and Eisai, Co., Ltd.’s Alzheimer’s disease treatment Aduhelm (aducanumab-avwa) on June 7, 2021, garnered an immense amount of attention would seem to be an understatement. That said, the drug has somehow gathered even more notice over the past few months due to multiple developments, with CMS most recently issuing a proposed National Coverage Determination (NCD) on Aduhelm and other monoclonal antibodies that target beta amyloid plaque that will allow Medicare coverage for the therapies but only under certain circumstances. While commercial payers often follow CMS’s lead, it remains to be seen whether that decision — plus a dramatic price cut on Aduhelm — will prompt payers that have declined to cover the therapy to change course.

There is a 30-day public comment period on the proposed NCD, which was published Jan. 11. A final decision is expected on April 11.

More than a year after pandemic travel restrictions pushed back the FDA’s approval decision on Novartis Pharmaceuticals Corp.’s inclisiran, the agency finally approved it. The new first-in-class therapy targets so-called bad cholesterol and is set to compete with two other biologics that target the same protein.

On Dec. 22, the FDA approved Leqvio as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia who require additional lowering of low-density lipoprotein cholesterol.

As part of a sweeping new Medicare Advantage rule, CMS recently proposed a policy aimed at reforming a reimbursement system that local pharmacies have long claimed is straining them to the breaking point. PBMs, on the other hand, argue that the proposal could hamper value-based contracting in Part D and potentially increase Medicare spending.

At issue are arrangements in which Part D plan sponsors can recoup money from pharmacies for dispensed drugs if the pharmacies do not meet certain metrics. Generally speaking, these payments to plan sponsors are known as price concessions, and when assessed retrospectively — as they currently are — they are counted as direct and indirect remuneration (DIR).

On Jan. 10, the U.S. reported 1.35 million new coronavirus cases as the highly contagious Omicron variant swept across the nation, breaking the previous daily record of 1.03 million. While a COVID-19 vaccine booster could increase immune response, the Centers for Disease Control and Prevention’s data show that only 36.7% of fully vaccinated people have received a booster dose nationwide, as of Jan. 11, 2022. Doubling the pace of booster vaccinations per day could prevent more than 41,000 deaths and 400,000 hospitalizations by the end of April, according to a recent analysis by The Commonwealth Fund.

As 2021 began, the pharmaceutical topic arguably drawing the most attention was COVID-19 and the rollout of vaccines against it. Moving into 2022, the COVID pandemic unfortunately continues to dominate headlines, as the U.S. marked 1 million new cases of COVID on Jan. 3, a single-day record for any country. However, it’s not all bad news, as the pandemic is continuing its impact across various services. For example, drugmakers are applying knowledge gained in their innovative efforts to develop vaccines and treatments to other areas of drug development, and a shift to virtual operations and health care is expected to continue.

AIS Health spoke with a variety of industry experts about their 2022 projections for pharma.

Paroxysmal nocturnal hemoglobinuria (PNH) is an ultra-rare, potentially fatal disease. The FDA approved the first therapy, Alexion Pharmaceuticals, Inc.’s Soliris (eculizumab), a complement C5 inhibitor (C5I), to treat adults with the condition on March 16, 2007. Then the agency approved another C5I to treat adults with PNH from the same company, Ultomiris (ravulizumab-cwvz), on Dec. 21, 2018. A recent study of those two therapies from Prime Therapeutics LLC shows that there may be opportunities for payers in PNH management that will result in better health care outcomes for their members.

Prime presented findings from the study at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting, which was held Oct. 18 through 21 in Denver. Funding for the study was provided by Apellis Pharmaceuticals, Inc., manufacturer of Empaveli (pegcetacoplan), a C3 inhibitor approved May 14, 2021, for the treatment of PNH in treatment-naïve people, as well as ones switching from any C5I. Researchers were from Prime, Apellis and the University of Minnesota College of Pharmacy.

Within the span of one week, Secura Bio, Inc. has revealed that it will withdraw one oncology drug from the U.S. market, as well as an indication for another oncolytic. The FDA had given both accelerated approval. The moves come amid growing scrutiny of that approval pathway, and they mark the ninth and 10th oncology indications and/or drugs taken off the U.S. market since December 2020.

Secura Bio said on Nov. 30 that it will withdraw the new drug application for Farydak (panobinostat). The FDA granted the capsule accelerated approval on Feb. 23, 2015, for the drug in combination with Takeda Pharmaceuticals U.S.A., Inc.’s Velcade (bortezomib) and dexamethasone for the treatment of people with multiple myeloma who have received at least two regimens, including Velcade and an immunomodulatory agent. That indication is the only one the drug has in the U.S. The company said it will continue to market the drug in other areas in which it is approved.

Founded as a consumer-oriented, technology-focused startup in 2015, Bright Health has quickly made its presence known in the health care industry, despite its newcomer status. The company launched its first product offerings in Colorado's individual market in 2016 and has since expanded to offering individual, Medicare Advantage (MA) and small group plans in 17 states. Bright Health's value-based care model revolves around partnerships with select health and hospital networks, including Tenet Health, Novant Health and HCA Healthcare, emphasizing the importance of the patient-provider relationship. CVS Caremark serves as Bright Health's pharmacy benefits manager.

Almost 12.8 million adults delayed or did not get prescription drugs in 2018-19 due to costs, including about 3.8 million privately insured nonelderly adults and 2.3 million elderly Medicare beneficiaries, according to a study by the Robert Wood Johnson Foundation and Urban Institute based on 2018–19 data from the Medical Expenditure Panel Survey. About 9.5% of adults who were uninsured all year reported unmet prescription drug needs, compared with 4.9% of Medicare beneficiaries and 5.6% of nonelderly Medicaid enrollees. More than one-quarter of adults with Medicare and 5.3% of privately insured people spent more than 1% of their family incomes on out-of-pocket prescription drug costs. In November, the House of Representatives passed the Build Back Better Act, which includes provisions seeking to bring down drug costs, but the bill’s fate in the Senate is in peril.

While the COVID-19 pandemic still drove a lot of the conversation around the pharmaceutical industry over the past year, much of it was focused on the development of vaccines and their rollout starting in late 2020, as well as treatments for the virus. But other innovative agents also came to market in 2021, continuing the industry’s trend of producing pioneering products. AIS Health, a division of MMIT, spoke to industry experts about the impact of COVID-19 on the industry and other 2021 pharma trends.