RxStrategies Clinical Insights – October 2014, Issue 1

    New Drug Approvals

    Esbriet® (pirfenidone), Ofev® (nintedanib)– New Drug Approval (Orphan Drug)
    October 15, 2014 – The U.S. Food and Drug Administration announced the approval of Esbriet® (pirfenidone) and Ofev® (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF). IPF is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation and lung transplant.

    RxS Clinical Insight: Esbriet® (pirfenidone) is a small molecule orphan drug dosed orally with an anticipated cost of $94,000 annually. Expected the product to be available via limited distribution to select specialty pharmacies.

    Learn more about Esbriet® from the announcement on FDA.gov.


    RxS Clinical Insight: Ofev® (nintedanib) is an orphan drug dosed orally. Boehringer Ingelheim (BI) has not released cost estimates at this time, but expect the price to be similar to new IPF product Esbriet®. BI has indicated that the product could be available in 10 days; expect the product to be available via limited distribution to select specialty pharmacies.

    Learn more about Ofev® from the announcement on FDA.gov.


    Harvoni® (ledipasvir and sofosbuvir) – New Drug Approval
    October 10, 2014 – The U.S. Food and Drug Administration announced the approval of Harvoni® (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni® is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin.

    RxS Clinical Insight: Harvoni® combines Sovaldi® (sofosbuvir) with a new drug (ledipasvir). The cost of Harvoni® for 12 weeks of therapy will be approximately $94,500, versus Sovaldi® alone at a cost of $84,000. Interestingly, Harvoni® is approved for 12 weeks of therapy, but in one pivot trial, 12 weeks of therapy did not result in a statistically significant cure rate over eight weeks of therapy. Expect payers to try to limit therapy to eight weeks in some patients to control cost.

    Learn more about Harvoni®  from the announcement on FDA.gov.


    Akynzeo® (netupitant and palonosetron) – New Drug Approval
    October 10, 2014 – The U.S. Food and Drug Administration announced the approval of Akynzeo® (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo® is a fixed combination capsule comprised of two drugs. Oral palonosetron (Aloxi®), approved in 2008, prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy.


    New Drug Indications

    Velcade® (bortezomib) – New Indication
    October 10, 2014 – Takeda Pharmaceutical Company Limited announced the U.S. Food and Drug Administration approved Velcade® (bortezomib) injection for use in previously untreated patients with mantle cell lymphoma (MCL). Velcade® is the first treatment in the United States to be approved for use in previously untreated patients with MCL.


    Eylea® (aflibercept) – New Indication
    October 6, 2014 – Regeneron Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration approved Eylea® (aflibercept) injection for the treatment of Macular Edema following Retinal Vein Occlusion (RVO), which includes Macular Edema following Branch Retinal Vein Occlusion (BRVO), in addition to the previously approved indication of Macular Edema following Central Retinal Vein Occlusion (CRVO).

    Learn more about Eylea® from the announcement by Regeneron Pharmaceuticals, Inc.


    New Drug Shortage

    October 16, 2014

    October 15, 2014

    October 14, 2014

    October 8, 2014

    October 7, 2014

    October 6, 2014

    October 3, 2014

    October 1, 2014


    New Drug Recall

    Ketorolac Tromethamine Injection: Recall – Incorrect Labeling
    October 6, 2014 – Sagent Pharmaceuticals, Inc. issued a voluntary nationwide recall of three lots (lot numbers: MP5021, MP5024 and MP5025) of Ketorolac Tromethamine Injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02), manufactured by Cadila Healthcare Limited and distributed by Sagent. The affected product was labeled with the incorrect expiration date. The labeled expiration date is longer than the known stability of the product.

    Learn more about Ketorolac Tromethamine Injection from the announcement on FDA.gov.


    Clinical and Pharmacy News

    How to Make the Best of the Medicare ‘Donut Hole’
    October 15, 2014 – The Medicare prescription drug “donut hole”—the difference between what a beneficiary pays for after reaching the initial coverage limit and the amount the government pays for “catastrophic” drug coverage—is quickly closing. Thanks to reforms under the Affordable Care Act, seniors covered under Medicare Part D paid less for prescription drugs in 2014 than they did last year, and the premiums for prescription drug coverage are less expensive than they were in 2013.

    Learn more about the Medicare prescription drug “donut hole” from U.S. News & World Report.


    Big Pharma Cashes in on Americans Paying (Higher) Prices for Prescription Drugs
    October 15, 2014- Life changes for anyone dealing with a chronic illness or life-threatening disease, starting with cancer. Patients and family members automatically cope with extraordinary amounts of stress and anxiety. Many people find that coming to terms with a serious medical battle is only part of the story. The other part is money. It costs a lot of money to be sick in America, and it turns out that Big Pharma employs business tactics to ensure that the cost is higher than it needs to be.

    Learn more about Big Pharma from Drugwatch.com.


    FDA: Little Evidence to Drop Chantix Boxed Warning

    October 15, 2014 Federal regulators say Pfizer, Inc. has provided low-quality evidence to support its request to remove a bold-letter warning about suicidal behavior from its anti-smoking drug CHANTIX® (varenicline). The twice-a-day tablet has carried the Food and Drug Administration’s strongest warning label, known as a black box, since 2009, following reports of suicidal tendencies, hostility and depression among some patients.

    Learn more about CHANTIX® from Drug Discovery & Development.


    Prescription Drug Expenses Seen Steady for Next Decade
    October 14, 2014 – The United States spent $2.9 trillion on health care last year. Hospitals make up the single-largest share (31%) of the total, followed by doctors and clinics (20%) and prescription drugs (9%). Yet this picture is somewhat misleading. About $109 billion in prescription drug spending last year was obscured within the $2.9 trillion total for U.S. health spending released by federal officials this fall, economists with the Altarum Institute said in a new report.

    Learn more about prescription drug expenses from Modern Health.


    Senate Dem Calls for Prescription Drug Regs
    October 14, 2014 – Sen. Ed Markey (D-Mass.) is calling on federal regulators to address growing problems with prescription drug abuse. In letters to the Department of Justice and the Department of Health and Human Services, Markey asks for the agencies to combat what he refers to as an “opioid epidemic.”

    Learn more about prescription drug abuse from The Hill.


    New Biosimilar Pathway Paves Way for U.S. Approvals
    October 6, 2014 – With the recent announcement the FDA has accepted its first biologics license application (BLA) for a biosimilar version of filgrastim, many stakeholders are wondering how the drug will affect formulary decision making and drug costs. Sandoz’s BLA for filgrastim (granulocyte colony-stimulating factor [G-CSF]) will be the test case for the FDA’s new biosimilar approval pathway, giving the U.S. market access to these products.

    Learn more about the biosimilar approval pathway from ClinicalOncology.


    Women Should Not be Prescribed Testosterone Therapy
    October 6, 2014 – Healthy female patients should not be diagnosed with testosterone deficiency or prescribed testosterone therapy, according to a clinical practice guideline written by the Endocrine Society..

    Learn more about testosterone therapy from the Journal of Clinical Endocrinology and Metabolism.


    Express Scripts Collaborates with Walgreens to Create Value-Driven Medicare Prescription Drug Plan Pharmacy Network
    October 1, 2014 –A new preferred pharmacy network is offering seniors $0 and $1 copayments on Tier 1 generics. Express Scripts announced its two nationally available 2015 Express Scripts Medicare® Prescription Drug Plans (PDP) will offer a preferred retail pharmacy network, featuring Walgreens helping America’s seniors obtain more value, choice and clinical support for their Medicare dollars.

    Learn more about preferred pharmacy networks from the Journal of Clinical Endocrinology and Metabolism.


    Celebrate Pharmacy During American Pharmacists Month
    September 30, 2014 – In celebration of American Pharmacists Month, pharmacists are encouraged to spread the word about their work throughout the month of October. “American Pharmacists Month is a time to recognize pharmacists for the vital contributions they make to health care in the United States through improved medication use and advanced patient care,” the American Pharmacists Association (APhA) states on its website. “(It) is a time to educate your patients, motivate your staff, and engage and inspire your community to ‘Know Your Pharmacists, Know Your Medicine.’”

    Learn more about American Pharmacists Month from Pharmacy Times.


    340B News

    Are Hospitals Abusing the 340B Drug Discount Program? New Study Reignites Controversy
    October 7, 2014 – A new Health Affairs study has fueled the debate over the 340B drug discount program by concluding hospitals use the program to boost profits rather than help low-income and uninsured patients.

    Learn more about 340B abuse from Health Affairs.


    New Challenge to 340B Rule Regarding Orphan Drugs
    October 13, 2014 – On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services Administration (HRSA) and each body’s respective secretary in the U.S. District Court for the District of Columbia. PhRMA is seeking declaratory and injunctive relief to prevent HHS from re-issuing a rule related to the 340B Federal Drug Pricing Program (340B Program)’s so-called “orphan drug exclusion.”

    Learn more about this complaint from The National Law Review.