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Pharma Campaigns Against California Price Transparency Bill

A life sciences trade group in California is fighting back against a price transparency bill approved by the state Senate. The bill requires biopharmaceutical companies to report drug price increases of more than 10% or drugs that will cost more than $10,000 a year. The California Life Sciences Association (CLSA) introduced a digital campaign opposing the bill, which could be signed into law as early as August. The California Senate approved the bill 24-8, allowing it to move on to the state assembly. Legislators assert that the law would increase pricing transparency and would help educate consumers on the cost of healthcare as a whole. CLSA, however, argues that the bill will not help patients, will only increase paperwork, and will decrease drug companies’ ability to broker discounts with insurance companies and others.

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FDA Loosens Restrictions on ‘Compassionate Use’

The Food and Drug Administration (FDA) has reduced the paperwork required by providers who wish to use investigational, not-yet-approved drugs for patients with life-threatening illnesses. The FDA’s new expanded access (“compassionate use”) application has only 11 questions and takes around 45 minutes, vs the prior 26-question application. The new form is intended for use with individual patients only. The decision came after the FDA recognized that the time-consuming, difficult-to-navigate nature of the paperwork may have discouraged providers from applying for expanded access. The reform is part of a larger effort to help patients with incurable disease live longer by making experimental drugs more accessible. Typically, either the unapproved drugs are part of a clinical trial and the patient does not meet the trial requirements, or a trial is not available. Still, some worry that the shorter forms will not ease the process enough. A voluntary letter of authorization is still needed from the drug manufacturer prior to the FDA’s review; manufacturers will often reject such applications for liability reasons or because it believes that the drug is not appropriate for that patient. While 99% of applications are approved by the FDA, the majority are stopped by the drug manufacturers.

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FDA Approves Allergan Antihypertension Drug

Allergan announced FDA approval of antihypertension drug Byvalson, a combination of nebivolol, a beta-blocker, and valsartan, an angiotensin-II receptor blocker. Nebivolol’s mechanism of action is not completely known, but it is believed to lower blood pressure via vasodilation, reduced heart rate, and other factors; valsartan blocks the aldosterone-secreting and vasoconstrictive effects of angiotensin-II. Patients taking the new combination drug saw a statistically significant reduction in blood pressure vs placebo in 2 clinical trials. Patients also experienced a greater reduction in blood pressure with Byvalson than with either nebivolol or valsartan alone. Byvalson will enter the market in the second half of 2016.

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CMS Updates ACO Shared Savings Rules

Thanks to updated rules from the Centers for Medicare & Medicaid Services (CMS), accountable care organizations (ACOs) in the Medicare Shared Savings Program will now be held to regional—not nationwide—spending benchmarks. The updates came after complaints that the original rules made it difficult for providers to see payouts: Only 92 of 333 ACOs received a shared savings payout last year. The revised rule will allow ACOs to have their spending standards modified on a regional basis after their first 3-year agreement period. The changes include lowering the weight placed on regional adjustment each year and updating regional benchmarks yearly to account for fee-for-service (FFS) spending changes. The rules also set time limits for ACOs to dispute any payments or fines levied over errors or fraud. Any county in which an ACO has a beneficiary will be taken into account when calculating regional benchmarks, and the same benchmarks will be applied across all types of Medicare beneficiaries. The Shared Savings program was intended to encourage healthcare providers in ACOs to enhance care coordination and decrease FFS spending. As an ACO advances, it takes on risk in which its reimbursement is tied to its performance.

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Jane DuBose

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