Chain Drug Review, June 4, 2018

108 Chain Drug Review June 4 2018 Generic Drugs Biosimilar for Anemia The FDA approved Retacrit epoetin alfaepbx a biosimilar to Epogen Procrit epoetin alfa Made by Hospira a Pfizer Inc company Retacrit is OKd for use in averting the need for blood transfusions with surgery Generic Welchol OKd The FDA approved Glenmark Pharmaceuticals generic version of Daiichi Sankyos Welchol colesevelam HCl tablets 625 mg indicated to reduce elevated levels of LDL cholesterol FDA starts exposing anticompetitive tactics Focus SILVER SPRING Md The Food and Drug Administration has begun shining a light on possible attempts by branded drug makers to game the system to delay generic competition The agency last month made public a list of branded manufacturers that may have been blocking access to the samples of their products said FDA Commissioner Scott Gottlieb We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval he said We often hear of these tactics when it comes to generic drug developer access to samples when the brand products are subject to limited distribution programs In some instances limitations on distribution may be imposed in connection with a risk evaluation and mitigation strategy REMS which the FDA implements for certain drugs to help ensure that their benefits outweigh their risk We have heard that some drug makers have either refused to sell samples of products with REMS with elements to assure safe use ETASU impacting distribution to potential generic competitors or have imposed conditions on the sale of such samples that generic companies find hard or impossible to comply with said Gottlieb Chip Davis president and chief executive officer of the Association for Accessible Medicines said that President Trump Health and Human Services Secretary Alex Azar and Gottlieb promised to take immediate action to increase competition and combat brand name drug companies abuse of FDAs safety rules Publicly listing the bad actors who have for years denied access to samples reveals which companies are putting profits ahead of patients Pharma companies are inured to shaming added Davis To end the shenanigans once and for all Congress must pass the bipartisan market based CREATES Act Increasing patient access to more generics and biosimilars is a proven solution to lowering the cost of prescription drugs We look forward to working with the Trump administration and leaders in Congress to enact the CREATES Act into law and deliver a win for Americas patients He said he was encouraged by a statement from House speaker Paul Ryan R Wis that the legislative body was working to pass the legislation Davis said Its important that Congress gets this right Any compromise must ensure the timely approval by FDA of safe effective and more affordable versions of pricey brand medicines Any compromise must also provide strong enough enforcement to deter bad actors from gaming the rules that were never intended to be used to protect their monopoly at the expense of patients Gottlieb said no patients should be priced out of medicine needed to support health As stressed by the president and Azar one of the administrations highest priorities is advancing policies to increase competition to help make drugs more affordable and improve access the commissioner noted There isnt one single action thats going to solve this issue he said We will achieve these public health goals through the coordinated effort of different federal agencies working in partnership with industry and other stakeholders The FDA is taking steps across a broad range of areas to improve new and generic drug competition as a way to improve access and affordability It is especially focused on addressing tactics we sometimes hear of branded companies pursuing as a way to forestall expected generic entry One such abuse that Gottlieb has spoken about frequently is branded companies hindering generic developers from purchasing samples of their drugs In general generic drug makers need the samples to develop their generic product and or to conduct testing to show that their product is bioequivalent to the brand A generic drug developer typically needs 1500 to 5000 units of the brand drug to perform what are often relatively straightforward studies for FDA approval Without these samples generic drug makers may not be able to develop generic alternatives Gottlieb commented Yet the FDA has heard that some brand companies will adopt tactics to make it hard for the generic companies to purchase these brand drugs at a fair value and in the open marketplace The FDA is taking new steps to address this issue Branded companies have also placed restrictions in contracts with drug distributors or specialty pharmacies that limit the ability of these intermediaries to sell samples to generic manufacturers for testing noted Gottlieb But I want to be very clear A path to securing samples of brand drugs for the purpose of generic drug development should always be available he remarked Even in the case of limited distribution programs such as those required by certain REMS there should be a path forward for generic drug development The FDA he pointed out has received more than 150 inquiries from generic drug developers seeking help in obtaining samples from brand companies Upon receipt of such inquiries the agency is taking several steps to determine the factors at play and appropriate next steps First the FDA will determine whether the products have in place a REMS program with ETASU that may impact distribution which has been cited as a reason to refuse to provide samples In many cases it finds that there is no such REMS program in place In these cases the FDA informs the generic drug company that there are no FDA required restrictions on the distribution of the drug that would impede obtaining samples The agency is also notifying the Federal Trade Commission which is responsible for addressing anticompetitive business practices about these inquiries It also encourages generic manufacturers to raise these cases with the FTC if they believe that anticompetitive conduct has taken place Many of the products that we have received inquiries about are not subject to REMS with ETASU Gottlieb said This suggests that brand companies may be inappropriately using limited distribution to impede generic drug competition But even in cases where the FDA confirms there is an existing REMS program with ETASU for the brand drug that impacts distribution generic drug makers should be able to secure samples of the product he added To facilitate the transfer of samples in these cases the FDA has a voluntary process through which generic Scott Gottlieb FDA commissioner companies can submit their bioequivalence testing protocols and the agency will evaluate these protocols to ensure that their testing plan contains safety protections comparable to the brand products REMS program Assuming that the generic drug developers plans include appropriate protections the generic drug developers can request that the FDA send a letter to the branded company stating that the REMS program does not mean the brand drug maker cant sell its product to generic drug developers for comparative testing These notifications are called Safety Determination Letters To date the FDA has issued 21 of these letters in response to requests from generic drug companies Study Part D generics prices do not reflect market innovative medications they have responded with increased utilization management and tier placement strategies to moderate the average cost of covered drugs on each tier If a plan is faced with higher priced branded drugs one way it can reduce the overall average price of all drugs on a particular formulary tier is to increase the number of lower cost generics on that same tier Since the implementation of Medicare Part D in 2006 plan benefit designs have evolved and on average include a growing number of formulary tiers In 2018 more than 80 of Part D plans have five tiers compared WASHINGTON Seniors with Medicare prescription drug plans Part D pay more for generic drugs even as their market price stays stable according to a new report from Avalere Health Seniors are paying more because generic drugs are being placed on higher formulary tiers where patients pay more out of pocket for drugs the study found The number of generic prescription drugs placed on the lowest tier where patients pay less for their drugs declined 53 percentage points between 2011 and 2015 This shift resulted in a 93 increase in total patient cost sharing for these drugs or a total of 62 billion This higher cost sharing and movement of generics to higher tiers did not correspond with an increase in the underlying price of generic drugs over that same time period according to an analysis by Avalere experts of the average volume weighted price of generics that were included on plan formularies in both 2011 and 2015 The use of generic drugs has saved the Medicare Part D program billions of dollars said Avalere president Dan Mendelson However higher tier placement of generic drugs is leading to higher out of pocket costs for patients and may reduce savings As plans face pressure to cover new to 2006 when about half of all plans had only four tiers Part D plans have considerable flexibility as to how they design formularies and tier structure as long as they meet CMS nondiscrimination requirements In 2011 71 of generic drugs were placed on tier 1 the lowest tier in the formulary By 2015 19 of covered generics were placed on tier 1 while 46 were placed on tier 2 and 35 were placed on tier 3 or higher This shift represents a 53 percentage point decrease in the number of generics being placed on the lowest tier between 2011 and 2015 Additionally this movement from tier 1 to higher tiers was observed across all generics irrespective of price In fact there was a greater percentage point change in the number of generics costing less than 100 that moved from tier 1 to higher tiers compared to generics overall 53 change Continuing to realize the cost savings from high generic utilization requires further examination of the factors driving the shift of generic drugs to higher tiers and its impact on patient access said Clara Soh director at Avalere Funding for the analysis was provided by the Association for Accessible Medicines In 2015 patients spent more than 6 billion in additional out of pocket costs on generic drugs compared to 2011 These increased out of pocket expenses on low cost generics are being used by the plans to mask increases in branded drug prices said AAM president and CEO Chester Chip Davis Jr Avalere analyzed prescription drug event data and Medicare Part B FFS claims for 2016 under a CMS research agreement It analyzed a cohort of patients representing less than one in five total beneficiaries the cohort included beneficiaries identified as receiving new cancer treatments during 2016 Tier Placement of Generics 2011 2015 Percent Distribution of Generic Drugs on Part D Formulary Tiers 2011 To 2015