Thursday, February 16, 2017

The Epinephrine Auto-Injector Market is Changing – A Look at the Landscape in 2017

Two thousand and sixteen was a trying year for those who need to carry epinephrine auto-injectors. With the recall of Sanofi’s Auvi-Q in 2015, patients were left with few options, and in many cases, unaffordable price tags, forcing some families to make some tough budget choices. Mylan CEO, Heather Bresch, was called to task by the media and Congress for what some called price-gouging, given the market dominance of the Epi-pen (Mylan’s branded epinephrine auto-injector) following the disappearance of the Auvi-Q and the lack of new auto-injectors being approved by the FDA.

But 2017 is a new year and with it comes change – most, in my opinion, for the better. Let’s take a look:

Choice – There are more epinephrine auto-injectors on the market, and most notably, Auvi-Q is back! Kaleo Pharmaceuticals re-acquired the rights to market the Auvi-Q and have re-introduced it to the market. Consumers and doctors can now choose between Mylan’s Epi-pen, Kaleo’s Auvi-Q, and Amedra’s Adrenaclick. So there is choice… sort of.


Generics
– In response to the uproar over Epi-pen pricing, Mylan launched a generic version of their epinephrine auto-injector, with a price tag of $300 for a twin-pack versus the $600 for the branded version. It’s the same device, same drug, with different labels. Early this year, CVS introduced a generic version of the Adrenaclick – available for $110 for a twin-pack, only at CVS Pharmacies. This would seem to be progress, but it’s important to note that – for most of us with insurance – the Pharmacy Benefit Managers (PBMs) make the decisions about what a plan will cover. The PBMs have a track record of dropping coverage for a brand name drug when a generic is available, and dropping coverage for a drug altogether when it available over the counter.

Innovative access solutions
– And it’s not just the PBM’s that take a cut of the profits. Take a look at Mylan’s chart which describes the problem. There are insurance companies, wholesalers, and pharmacies involved in the supply chain for drugs. This is why I am very excited about Kaleo’s recently announced access program for the Auvi-Q. The Auvi-Q Afford-ability program bypasses the middlemen. In my opinion, this is a game-changing solution to a supply chain problem and is a particularly well-suited solution for a prescription that doesn’t need to be taken every day or filled every month. Most epinephrine auto-injectors go unused (thankfully) and need to be replaced just once a year.

Pricing all over the map – So there is a lot going on, and that is causing some interesting pricing dynamics. On my plan (CVS Caremark), the generic Adrenaclick is the only epinephrine auto-injector covered without the need for prior approval (at a cost of $370 with $20 out of pocket). The brand Adrenaclick (with approval) costs $456, with $210 out of pocket. Neither version of Mylan’s Epi-pen (brand or generic) is covered by my plan in 2017. (In 2016, the Epi-pen was covered at a cost of around $600 with out-of-pocket cost around $100). My prescription plan covers the Auvi-Q only with pre-approval; it is listed at a price of $8910 for a pack of four, with $210 out of pocket. It's not clear whether my insurance plan would cover a twin pack of Auvi-Q, but the official list price for a twin pack of Auvi-Q is $4500. But remember, all that matters is how much you actually pay. When your Auvi-Q prescription is filled directly through Kaleo’s Afford-ability program, if you have insurance, the out of pocket cost is $0.

And there are still wildcards
. What will happen with the Affordable Care Act? Will Congress take action on drug pricing? And more specifically, will they address the supply chain issues plaguing affordable access to drugs?

Watch this space…

Note: all prices and co-pays noted here are from the CVS Caremark tool for my insurance plan and may not reflect the pricing you will see.

Monday, January 9, 2017

Whole Cranberry Sauce

It was Thanksgiving. Plates of turkey, mashed potatoes, and veggies were being passed around the table. My son asked if we had cranberry sauce. We didn’t.

Never be without cranberry sauce again! This gluten-free, vegan, and allergy-friendly cranberry sauce is made with whole cranberries and Sucanat.

I had made a deliberate decision not to make cranberry sauce.

Here’s the back story: I have made cranberry sauce for every Thanksgiving dinner for – forever – or at least as long as I have been preparing Thanksgiving dinner. In recent years it seems that I am the only one who eats the cranberry sauce and the leftovers eventually get thrown away. I didn’t think the cranberry sauce would be missed. I was wrong.

So when I saw the last of the season’s cranberries on sale at the grocery store, I decided to go all in. But instead of freezing the cranberries, I chose to make cranberry sauce and preserve it.

Use a water bath to take advantage of the last of the season's cranberries; make whole cranberry sauce.

Whole Cranberry Sauce

Makes 6 to 6 ½ half-pints

3 (12-ounce) bags of cranberries
2 ½ cups Sucanat (another granulated sugar, e.g., organic cane sugar may be substituted)
1 ½ cups apple juice
2 tablespoons lemon zest
3 tablespoons fresh lemon juice

If you plan to preserve the sauce, as I did, then start a boiling water bath with jars.

Combine the cranberries, Sucanat, juices and zest in a large nonreactive pot over high heat. Once it reaches a rolling boil, reduce the heat to medium. Boil for 15 to 20 minutes until all of the cranberries have popped and the sauce is thickened.

Whole Cranberry Sauce. Just tangy enough, just sweet enough!

If you are preserving, fill the jars (leave ½ inch headspace) and process in a water bath for 10 minutes. (Full details on using a water bath and preserving techniques can be found in The Allergy-Free Pantry.)

This sauce is tangy and lightly sweet. It can be used as a side with your favorite dish or spread on your bagel or toast as a jam.

Never be without cranberry sauce again! Gluten-free, vegan, allergy-friendly.

I love having these jars in my pantry. Next time someone asks for cranberry sauce at my dinner table, I will be ready!

Monday, December 12, 2016

Low Histamine Maple Oatmeal Cookies

Lately, I have been suffering from sneezing and congestion fits that look and feel a lot like allergy. To date, I have been unable to determine what the culprit is. I am, however, certain that this is related to food. After about a month of food journaling I am suspicious that this may be a histamine problem, as there are simply too many foods – including foods I have been eating for years without an issue – that seem to set off these reactions. (I am also still suspicious that I may have a true food allergy to sunflower seeds – a prospect that makes me sad… no more SunButter cups…)

I have nonetheless embarked on a low histamine diet. Note that there is no way to be on a no histamine diet, as all food contains histamines, some more than others. And two of the highest histamine foods are chocolate and red wine (arguably my two favorite foods). This means no chocolate chip cookies for me. And I have switched to white wine (in moderation). What is a girl to do? Create a new recipe, of course.

Here is a cookie recipe that I have been perfecting for the last two weeks. It fits the low histamine requirements – even down to using vanilla sugar in lieu of vanilla extract – and I think you will agree that it satisfies the snack craving.

These cookies are gluten-free and top-8 allergen-free and meet the requirements of a low histamine diet.

Low Histamine Maple Oatmeal Cookies

128 grams (about 1 cup) gluten-free flour blend
½ teaspoon xanthan gum
½ teaspoon baking powder
2 tablespoons vanilla sugar (see below)
2 tablespoons canola oil
½ cup maple syrup
2 tablespoons applesauce
100 grams (about 1 cup) quick cooking gluten-free oats

Preheat the oven to 350 degrees. Line a baking sheet with parchment paper.

Combine the flour, xanthan gum (use this only if your flour blend doesn’t contain a gum), baking powder, and vanilla sugar in a medium bowl.

Combine the oil, maple syrup and applesauce in a large mixing bowl.

Add the dry ingredients and blend together well. Add the oats and blend for another 1-2 minutes.

Scoop the cookies onto a baking sheet. Flatten the tops.

Bake at 350 degrees for 15-16 minutes.

Vanilla Sugar

To make vanilla sugar, combine ½ cup organic cane sugar with one whole vanilla bean in the bowl of a small food processor. Process until the vanilla bean is completely combined.

Maple and oatmeal shine in these cookies that are gluten-free, dairy-free, soy-free, nut-free, egg-free, and alcohol-free!

In addition to being low in histamine, these cookies are of course gluten-free, dairy-free, egg-free, soy-free, and nut-free. They have just a touch of crunch, and just the right amount of soft-baked. And they smell soooo good while they are baking!