A male pharmacist is examining a drug from a pharmacy inventory.

HHS’ New Prescription Drug and Health Care Spending Rule

By Cathy Zhang

Today, the Department of Health and Human Services — alongside the Department of Labor, the Department of the Treasury, and the Office of Personnel Management — published an interim final rule requiring health insurance plans and issuers on the marketplace to report data on prescription drug and health care spending to the three Departments.

This rule is part of a series of rules issued by the Biden Administration to implement Title I (No Surprises Act) and Title II (Transparency) of the Consolidated Appropriations Act, 2021.

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Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

What Democrats’ Drug Pricing Plan Means for Consumers

By Cathy Zhang

At the start of the month, Democrats announced a new drug pricing plan, detailed in the House’s Build Back Better Act (H.R. 5376). In the immediate short term, the drug pricing plan has enabled the $1.75 trillion bill to go forward through the House. If ultimately enacted, it will generate savings for consumers, some more directly than others, and at a more modest pace and magnitude than many had hoped.

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close up of an open book

Monthly Round-Up of What to Read on Pharma Law and Policy 

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of September. The selections feature topics ranging from an analysis of the regulatory outcomes of cancer drugs that received accelerated approval and had negative post-approval trials, to an evaluation of how federal public funding contributed to the development of Pregabalin (Lyrica), to a systematic literature review of the criticisms against the use of the quality-adjusted life-year (QALY) in health technology assessments. A full posting of abstracts/summaries of these articles may be found on our website.

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a pill in place of a model globe

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Beatrice Brown, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of May. The selections feature topics ranging from an analysis of the impact of generic drug spikes on Medicaid spending, to an evaluation of where drugs are tested for FDA approval and subsequent time to marketing approval in these countries, to an assessment of how net prices of diabetes drugs are affected by brand competition. A full posting of abstracts/summaries of these articles may be found on our website.

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Hundred dollar bills rolled up in a pill bottle

New Rule Might Increase Out-of-Pocket Drug Costs for Patients

This blog post is adapted from a commentary published in the American Journal of Managed Care.

By Bryan Walsh andAaron S. Kesselheim

Patients may face increased out-of-pocket drug costs as a result of a new rule finalized by the Centers for Medicare & Medicaid Services (CMS) in July 2020 that would permit wide use of co-pay accumulator adjustment programs (CAAPs).

These increased costs may have effects on medication adherence, and in turn may affect health outcomes. In a recent commentary published in the American Journal of Managed Care, we explain the background to this rule and suggest ways CMS could narrow it to avoid these potential negative effects.

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Gavel surrounded by piles of money.

3 Challenges to Patents on Therapeutic Monoclonal Antibodies

By Gregory Curfman

Three new developments — two based on litigation and one based on a federal statute — may have significant effects on pharmaceutical manufacturers’ use of patents to fend off competition and maintain high prices for therapeutic monoclonal antibodies.

Highly specific monoclonal antibodies have played an increasingly important role as precision therapies for a growing number of diseases, including malignant, cardiovascular, and inflammatory conditions. As therapies derived from research and development, therapeutic monoclonal antibodies may be — and usually are — patented, providing manufacturers with protection from competition and the prospect of high revenues.

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Map of United States made up of pills.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of January. The selections feature topics ranging from an analysis of recent regulatory and legal developments in drug-pricing transparency, to an argument for the extent to which political actors should have influence over the FDA, to a descriptive analysis of state-level drug product selection laws. A full posting of abstracts/summaries of these articles may be found on our website.

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Hundred dollar bills rolled up in a pill bottle

AbbVie Wins First Round in Humira Antitrust Lawsuit

By Ryan Knox and Gregory Curfman

Since receiving FDA approval for Humira® (adalimumab) in 2002, AbbVie, the drug’s manufacturer, has filed hundreds of submissions to the U.S. Patent and Trademark Office for secondary patents – almost half of which were filed after 2014, just two years before the expiration of its core patent.

These patents were largely directed to methods of use and potential formulation changes, but they did not include claims that affect the clinical efficacy of the biologic, which is used in the treatment of rheumatoid arthritis, Crohn’s disease, and psoriasis, among other conditions. Instead, the purpose of the secondary patent filings was to assemble a thicket of patents, 132 in all, to prohibit competition from biosimilar companies.

And so far, the strategy has worked. AbbVie remains the sole U.S. manufacturer of the biologic, and has successfully defended its domain: in June 2020, a federal district court judge in Chicago dismissed an antitrust lawsuit against AbbVie.

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a pill in place of a model globe

Issuing the Most Favored Nation Interim Final Rule Was a Mistake

By Abe Sutton

While the Most Favored Nation (MFN) Interim Final Rule (IFR) advances a well-calibrated policy to standardize pharmaceutical prices across developed nations, procedurally, its issuance was a mistake.

The Trump administration would have been wiser to issue a Notice of Proposed Rulemaking (NPRM) for two reasons: first, an NPRM would have circumvented some of the procedural vulnerabilities of the IFR. And second, had the Trump administration issued an NPRM, President-Elect Biden’s team would have faced significant pressure to finalize the policy.

In this post, I touch on what MFN is, examine why the interim final rule is legally vulnerable, explore why the Biden team likely would have adopted the policy had an NPRM been issued, and explain how industry should think about this situation.

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