Thursday, December 18, 2014

Et Tu, Amgen? Blincyto's Bling! Bling! Price Tag!

FDA approved Amgen's Blincyto (blinatumomab) on December 3, 2014, as a second-line treatment for Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, which affects around 6,000 patients in the US.

The price tag of $178,000 per two-cycle course makes it one of the most costly drugs on the market.

This is just one of the record number of 15 "orphan" drugs approved by the FDA in 2014 (read "43% of New Drugs Approved by FDA in 2014 were for Treatment of Rare Diseases").

FDA considers Blincyto a "breakthrough" therapy, which means preliminary clinical evidence demonstrates the drug "may have substantial improvement on at least one clinically significant endpoint over available therapy."

On FDA Voice (FDA's blog), commissioner Margaret A. Hamburg said "Consider for example, Blincyto, approved just last week to treat Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia. CDER employed all of its expedited review programs to help get this drug to market as early as possible, five months ahead of its review goal date. The sponsor also benefited from incentives for drugs that treat rare diseases."

Despite the extraordinarily high price of Blincyto, payers are not likely to complain about the price as much as they complained about the price of Sovaldi. Read on to learn why I believe that is true.

Wednesday, December 17, 2014

Pfizer's "Humorous" Menopause Ad Mentions the "V" Word

Pfizer marketers have done it again! First it was an all-female Viagra ad campaign for the treatment of ED (erectile dysfunction; read "Oh Yeah, Baby! Show Me More!... Viagra TV Ads Like This. But Don't Let My FDA See It!").

Now, it's an all-female disease-awareness ad campaign about "vaginal atrophy," which appears to be a symptom of menopause that women don't talk about - hence the name of the video featured in the campaign: "The Talk" (it's embedded at the end of this post).

Three generations of women -- a teenager, her mom, and her grandma (mom's mom) -- act out how difficult it is for women to talk about "woman problems" as my mom would say.

The mom first tries to talk to her teenage caught about "becoming a woman." "Mom! I know!," says the daughter was she slams her bedroom door. Then, the mom acts the same way when her mom tries to talk to her about menopause. But her mom comes straight to the point: "What about changes to the vagina?," she asks. Grandma then "changes the dialogue" and specifically talks about vaginal atrophy.

Changing the dialogue -- the tagline for Pfizer's website -- is what Pfizer hopes this campaign accomplishes because it has a drug to sale: ESTRING - "a local estrogen therapy used after menopause to treat moderate-to-severe menopausal changes in and around the vagina."

Will this ad be criticized as was the Viagra ad?

Tuesday, December 16, 2014

43% of New Drugs Approved by FDA in 2014 were for Treatment of Rare Diseases

Preliminary data announced recently by the FDA shows that 2014 is shaping up to be a banner year for orphan drugs, which are drugs that treat "rare" diseases/disorder affecting fewer than 200,000 people in the U.S. The drug approval data from 1994 through 2014 (to date) are plotted in the following chart:

NME=New Molecular Entity, BLA=Biologic License Application; Source: "CDER New Drug Review: 2014 Update"
Let's dig deeper into the numbers.

Saturday, December 13, 2014

Back to the Future of Mobile Health Apps with Professor SYRUM's Nephew

There is no more cherished and insulting image of a scientist/researcher than the "mad scientist" persona often depicted in cartoons.

A case in point is "Professor SYRUM" from Boehringer's EU-only Facebook game of the same name (see "Happy Holidays from Professor Syrum"). That's him on the near left.

Recently, I became acquainted with an unnamed scientist (physician? pharmacist?) in an animated piece produced by IMS Health to promote its new mobile health app review program (see "Is IMS Health's Mobile Health App 'Certification' Program Doomed to #FAIL?"). That's him on the far left of the image shown above. Let's call him "Doctor IMS."

Do you see the similarities between Professor SYRUM and Doctor IMS? Read on to learn my theory about how they are related.

Friday, December 12, 2014

Is IMS Health's Mobile Health App "Certification" Program Doomed to #FAIL?

"Welcome to the wild, wild, west of mobile health apps," says the voice over of an IMS Health animated Youtube video (embedded at the end of this post) that promotes two new mobile health app services:

AppScript - "a secure, cloud-hosted mobile health prescribing solution that helps providers create custom app formularies to prescribe, reconcile and track mobile medical apps"; and 

AppNucleus - "the industry’s most secure app development and hosting platform that offers a flexible, cloud-based publishing platform and pre-built secure messaging, personal health record/wallet and survey tools."

Recall (here) that the IMS Institute for Healthcare Informatics published a report that included an analysis of about 10,000 apps among the 40,000+ healthcare apps available for download from the U.S. Apple iTunes app store and an assessment of the potential value they provide throughout a patient's journey. The assessment found that "healthcare apps available today have both limited and simple functionality... [and] do little more than provide information."

Obviously, there is a lot of room for the improvement of mobile health apps. I've written about this many times as it relates to the pharmaceutical industry (see, for example, Reigning in the "Wild West" of Mobile Health Apps and A Formula for Patient-Centric mHealth Apps).

Let's just focus on AppScript, which promises to "classify and evaluate more than 40,000 mobile healthcare apps currently available for download on iOS and Android platforms." I have some reservations about how successful this "Software-as-a-Service"/certification program will be.

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