This week’s Innovation Partners BioBlog looks at ideas shaping the future of healthcare. Trump’s new budget includes four items that, although unlikely to pass through Congress, give a glimpse into the president’s priorities. Oncology biosimilars are on the rise with physicians starting new patients on them more often than in the past. And ASCO lauds CMS for reflecting some of the organization’s statements in its 2021 and 2022 Medicare Advantage and Part D proposal. This and more in the Innovation Partners BioBlog.
From MA bonuses to 340B fees: 4 items you could have missed in Trump’s budget
The White House’s new 2021 budget has infuriated many healthcare groups. Changes to Medicare Advantage, major cuts to Medicaid, and many other items are all under fire. Although the budget is unlikely to pass through Congress, it provides insights into policies the Trump Administration is likely to pursue. There are four changes the administration is suggesting that bear watching: 1. Letting MA plans enter into any reimbursement 2. Eliminate requirements under MIPS 3. Removing the cap on MA benchmarks 4. Providing $34 million to boost 340B program oversight.
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Will Allergan’s specialty drug woes drag down post-merger AbbVie?
AbbVie might have been hoping that its merger with Allergan could add cash to its coffers, but weak fourth-quarter growth may prove otherwise. Allergan’s U.S. specialty generics business, which includes cosmetic and therapeutic Botox and the drugmaker’s facial aesthetics products, posted just 0.7% year-over-year growth in the fourth quarter to $1.82 billion. Critics contend that Allergan’s specialty unit may drag down AbbVie’s profits. In response, AbbVie plans to launch Allergan Aesthetics as a global subsidiary once the merger is complete.
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Pipeline Report: Oncology Biosimilars to Advance in 2020
New evidence suggests that biosimilars are gaining ground. According to Ann McNamara, Pharm. D., contributor to a drug pipeline report for the Specialty Therapies and Biosimilars Congress, prescribers are now starting new patients on biosimilars. In 2019, the FDA approved 10 biosimilars, among them products for breast cancer, metastatic stomach cancer, metastatic colorectal cancer, non-squamous non–small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, B-cell non-Hodgkin lymphoma, and chronic lymphocytic leukemia. In the oncology space, multiple launches of biosimilars for breast cancer medication trastuzumab and lymphoma/leukemia drug rituximab could happen in 2020, McNamara reported.
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Congress revives surprise billing debate with proposal for ‘mediation’
The House Ways & Means Committee released new legislation to tackle so-called surprise medical billing. The proposal calls for mediation to remedy unexpected medical bills. Payers are likely to balk at the solution and have suggested benchmarking out-of-network prices. Ways & Means wants to use a two-step process for resolving disputes. Either the provider or payer can start a 30-day period to resolve the dispute and the parties must exchange the required information. If the parties don’t reach a resolution, then either can kick-start a mediation process administered by a third party.
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Oncology and neurology treatments lead wave of new drugs in 2020
OptumRX predicts that the FDA will pay attention to many new drugs in 2020 but especially orphaned drugs, those drugs that treat rare or unusual medical conditions. OptumRx’s new Drug Pipeline Insights Reports predicts that the FDA will evaluate more than 150 new drugs for approval. Currently, 64 total drugs have been filed with the FDA and have anticipated approval dates in 2020. Eleven drugs are potential blockbusters with an expected $1 billion in U.S. sales.
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CRISPR-Edited Cells for Cancer Therapy Safe in Humans: Trial
A new study published in Science states that cells altered using CRISPR technology for cancer patients remain safe when used in humans. The study looked only at safety, but results indicate it may not offer a cure. CRISPR alters a person’s own T cells to battle cancer and has been lauded as a possible breakthrough in cancer treatment. One of the potential problems with CRISPR is the unintended consequence of altering the wrong genes. Although this did happen, the effects appear minimal. The clinical trial was deemed a success and showed the CAR-T therapy and CRISPR can be used together to target cancer cells.
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ASCO’s PBM Statement Shapes Medicare Advantage and Part D ProposalStatement By American Society of Clinical Oncology (ASCO)
The American Society of Clinical Oncology (ASCO) released a statement today thanking the Centers for Medicare & Medicaid Services (CMS) for including ASCO’s recommendations from the Society’s position statement on pharmacy benefit managers (PBMs) in the agency’s 2021 and 2022 Medicare Advantage and Part D proposed rule. ASCO’s August 2018 statement urged CMS to instruct contractors and PBMs to stop basing performance assessment and related direct and indirect remuneration (DIR) fees on current Star performance ratings. A separate DIR fee, known as a “claw back,” occurs when PBMs retroactively collect fees based on physicians’ and pharmacists’ performance on metrics that currently are not pertinent to oncology. ASCO called for the discontinuation of claw backs and for CMS to use measures and standards that are more appropriate to the specialty when evaluating the performance of dispensing physicians and practice-based pharmacies. The 2021 and 2022 Part D proposal was, according to ASCO, clearly shaped by the organization’s position statement.
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