Now Is the Time for Generic Epinephrine in New York State

If you carry an Epi-Pen, you are likely very much aware of the worldwide shortage of epinephrine since November of 2017. The price has also been skyrocketing. The upside is that this has brought more competition into the marketplace, as well as an effort to pass legislation permitting a generic to be substituted by a pharmacist whenever a patient is prescribed a brand name EAI device. Unless the doctor notes the prescription must be “dispensed as written,” a generic could be easily dispensed as long as it is the same dosage and strength and contains the same active ingredients. Read here about current efforts to get this legislation passed and other alternatives to the Mylan Epi-Pen.

Now Is the Time for Generic Epinephrine in New York State

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February 14th, 2019
By Jon Terry

Greetings. Concerning the New York State legislature and the 2019 session, recent developments have encouraged the Allergy Advocacy Association in our ongoing efforts to improve access to life-saving epinephrine for all individuals with life-threatening allergies. Those developments include substitution of generic drugs for brand-name medications. If new laws are enacted encouraging the use of generics by patients and consumers, lives will almost certainly be saved.

Up to 15 million Americans have food allergies, according to Food Allergy Research and Education (FARE), including about 5.9 million children under age 18, or 1 in 13 children. Many others are allergic to medication, latex, insect stings, or other triggers that can cause a sudden, potentially life-threatening reaction called anaphylaxis. Prompt administration of epinephrine is essential in an anaphylaxis emergency. 

New York State Senator Gustavo Rivera and Assembly Member Thomas Abinanti have reintroduced an act to amend the education law, in relation to the substitution of brand name epinephrine auto-injectors with alternate epinephrine autoinjectors for dispensation by pharmacists. Bill numbers S.3598 and A.1181 have almost identical text and are very similar to bills that were tabled in the legislature during 2018. Please see the critical language in each bill listed below.

(A) NOTWITHSTANDING SUBDIVISION TWO OF THIS SECTION OR ANY OTHER SECTION OF LAW TO THE CONTRARY, WHEN A PATIENT IS PRESCRIBED A BRAND NAME EPINEPHRINE AUTO-INJECTOR, A PHARMACIST MAY SUBSTITUTE AN ALTERNATE EPINEPHRINE AUTO-INJECTOR CONTAINING THE SAME ACTIVE INGREDIENTS, DOSAGE FORM AND STRENGTH AS THE BRAND NAME PRODUCT PRESCRIBED, ORDERED OR DEMANDED, REGARDLESS OF WHETHER THE ALTERNATE EPINEPHRINE AUTOINJECTOR IS INCLUDED IN THE LATEST LIST OF INTERCHANGEABLE DRUG PRODUCTS FOR THE PRESCRIBED EPINEPHRINE AUTO-INJECTOR DEVICE, PROVIDED THAT:

(I) THE PRESCRIBER DOES NOT INDICATE THAT THE PRESCRIPTION THEREFORE SHALL BE DISPENSED AS WRITTEN PURSUANT TO PARAGRAPH (A) OF SUBDIVISION SIX OF SECTION SIXTY-EIGHT HUNDRED TEN OF THIS ARTICLE;

(II) THE ALTERNATE EPINEPHRINE AUTO-INJECTOR AVAILABLE WOULD REFLECT A LOWER UNIT COST TO THE PURCHASER; AND

(III) THE PHARMACIST HAS ADVISED THE PURCHASER OF THE AVAILABILITY OF AN ALTERNATE EPINEPHRINE AUTO-INJECTOR AND OBTAINED CONSENT TO DISPENSE THE ALTERNATE EPINEPHRINE AUTO-INJECTOR.

https://nyassembly.gov/leg/?bn=A01181 

Our association believes that the ever-increasing costs of all kinds of medications demands regulatory clarity for prescribing and purchasing of generics. That is especially true of the EAI devices marketed here in New York State. At present our state does in fact have laws permitting substitution of generic medications for brand names. Please see info listed below.

Generic Medicine in New York State  
§6810. Prescriptions / Article 137 (6.a)

…Imprinted conspicuously on every prescription written in this state in eight point upper case type immediately below the signature line shall be the words: "THIS PRESCRIPTION WILL BE FILLED GENERICALLY UNLESS PRESCRIBER WRITES 'd a w' IN THE BOX BELOW". Unless the prescriber writes d a w in such box in the prescriber's own handwriting or, in the case of electronic prescriptions, inserts an electronic direction to dispense the drug as written, the prescriber's signature or electronic signature shall designate approval of substitution by a pharmacist of a drug product pursuant to paragraph (o) of subdivision one of section two hundred six of the public health law…. Immediately below such box shall be imprinted in six point type the words "Dispense As Written".

After review of the existing state regulations and the tabled bills from last year, our association is recommending additional amended language. It is intended to address concerns about the functional differences between regular branded epinephrine auto-injector (EAI) devices and the generic devices now entering the market. For example, it is true that some generics resemble a syringe and have a needle that is exposed throughout the injection process. However, they are easy to use once you are familiar with them; both types of devices operate in almost identical fashion. Here is our additional proposed text:

(IV) THE PHARMACIST HAS DEMONSTRATED THE OPERATING FEATURES OF THE ALTERNATE EPINEPHRINE AUTO-INJECTOR TO THE PURCHASER AND TRAINED THEM ON PROPER USAGE OF THE ALTERNATE EPINEPHRINE AUTO-INJECTOR IN AN ANAPHYLAXIS EMERGENCY.

Over the last decade, Mylan Pharmaceuticals the US company who owns the Epi-Pen™ brand, controlled 90% of the market and faced little competition for their Epi-Pen EAI device. Over that same time the Epi-Pen cost has soared from roughly $100 to over $600 per two-injector package (One prescription of EAI devices contains 2 auto-injectors). It will cost roughly $650 if you are paying cash, although pharmacy coupons or manufacturers discounts may lower the price. In December 2016 Mylan launched the first authorized generic for EpiPen at a 50% discount to its own brand name product. Using online coupons, consumers can get the authorized generic epinephrine auto-injector two pack from $150 to over $300 at some pharmacies. Some patients may be eligible for Epi-Pen or authorized generic discounts or co-pay coupon cards through Mylan and the Epi-Pen website.

Since November of 2017 there has been a world-wide shortage of the devices due to production issues with Pfizer, Meridian Medicals and Mylan Pharma. Australia, Canada, USA, and the UK have all reported national shortages of Epi-Pens, with some countries being entirely out of stock of the junior version. In western New York many pharmacies have had Epi-Pens on back order for weeks at a time.

A continuing online survey that Food Allergy Research & Education (FARE) began in August 2018, by December shows that 82 percent of 821 respondents report that they could not fill or could only partially fill prescriptions for Mylan’s devices. (The survey doesn’t reveal whether earlier participants were eventually able to locate the devices.) 

Mylan blames its manufacturer Meridian Medical Technologies for the shortage. But almost a year on from the first supply interruption, the issue remains unresolved and the exact cause remains a mystery. This lack of transparency and failure to resolve the issue is troubling, and further damages Mylan's reputation which has been plagued by accusations of prioritizing profit over patient welfare. Meanwhile, no formal announcements have been made as to just how long the current situation will continue. Improved access to generic EAI devices could help to remedy this life-threatening medical crisis for many patients at risk for anaphylaxis emergencies.

What will generics do for consumers? They will improve access and availability while also providing economic competition with brand names. If consumers purchase increasing numbers of generics that may encourage lower prices and more companies producing and marketing EAI devices.

There are already generic alternatives in the U.S. marketplace that are becoming increasingly popular and more readily available. For instance, many allergists are now prescribing the compact Kaléo’s Auvi-Q auto-injectors, which are often ordered via a directly delivery program and are also stocked at Walgreens pharmacies. 

For patients who are unable to fill their current epinephrine prescriptions, Walgreens pharmacists will work with each patient’s healthcare practitioner to see if AUVI-Q is right for them. Current AUVI-Q patients should continue to utilize kaléo’s Direct Delivery service to ensure delivery to their home. AUVI-Q 0.15 mg and 0.3 mg are available through Walgreens for patients with commercial insurance. Medicare patients should check with their individual health plan to verify their specific benefits, as AUVI-Q coverage varies by Medicare plan.

To learn more about AUVI-Q, please visit www.auvi-q.com

Among the generics available, the Amneal-Impax version of the Adrenaclick auto-injector is also growing in popularity, although it too still faces manufacturing delays, according to the FDA’s site. 

Teva Pharmaceutical Industries’ generic version of the EAI device 0.3 mg is now available, at least in limited quantities, with additional distribution of this generic and the 0.15 mg (for young children) expected in 2019. Their generic EpiPen product is priced at $300. That’s the same as what the Food and Drug Administration calls the “authorized generic” sold by Mylan.

Sandoz Inc., a Novartis division, is gearing up as well for the launch of its pre-filled epinephrine syringe, called Symjepi, for the first quarter of 2019. Sandoz will sell prefilled syringes with epinephrine under the name Symjepi. According to FiercePharma, the device has launched with a list price of $250 per pair. The price undercuts the list price of EpiPen generics from Mylan and Teva by $50, putting downward pressure on emergency epinephrine pricing.

Will the legislature take effective action before the current session concludes in mid-June? Our association certainly thinks it should. During previous sessions many of our supporters and affiliates have observed that in Albany no binding decisions are made well in advance of any deadline. Success on this issue will require plenty of patience and persistence by all interested parties both inside and outside of state government.

In the future if only one life is saved through improved access to epinephrine due to generic availability, that makes our efforts truly worthwhile.

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