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In a previous post—now almost one and a half years ago—I described "the coming storm" I anticipated would develop around the 340B drug discount program. After a brief tornado hit the House Energy and Commerce Committee when they considered including 340B reforms in their 21st Century Cures initiative, a slower, hurricane-style churn over the Administration’s proposed guidance on the topic has settled in…With the October 27 comment window steadily approaching, let’s take a look at what the rule says and what it could mean for interested stakeholders.

• A Brief History Of 340B
• What Happened At The Energy And Commerce Committee?
• What’s In The HRSA Guidance?

…Daiichi Sankyo will cut as many as 1,200 jobs in the U.S. as it braces for the loss of patent protection on top treatment Benicar (olmesartan) and shakes up the organization for a transition to a specialty portfolio in cardiovascular, pain management and oncology. "As we face the loss of exclusivity in the coming year of our largest product, we also look ahead to great opportunities...The cuts will come in the head office at Parsippany, New Jersey, and field-based sales…

Cost regulators for health technologies funded by the National Health Service in England and Wales have rejected a novel treatment for the genetic condition Duchenne Muscular Dsytrophy, seeking more data from the firm to confirm its benefit and justify its high cost...PTC Therapeutics’ Translarna (ataluren) is the first licensed treatment for DMD that addresses the loss of dystrophin, the underlying cause of the condition…NICE has recognised that the drug represents "an important development in the treatment of DMD and could potentially prolong the time before children have to use a wheelchair"…data…show that the therapy failed to achieve its main goal of significantly improving the distance achieved by patients in the standard six-minute walk test….the firm’s task of justifying the £220,256 ($340,000) per patient per year cost of the drug just got somewhat harder.

Leaders of India's $15 billion pharmaceuticals industry, a major supplier of affordable generics to the world, have joined public health activists in criticizing a new U.S.-led trade deal they say will delay the arrival of new cheap drugs…The impact of the Trans-Pacific Partnership struck last week between 12 nations…but not India, is still being studied by Indian drug makers. But in initial comments, industry executives said provisions in the deal that shield new drug data from competitors would hurt their business in those nations…Countries from the United States to Africa rely on India as a supplier of cheap medicines, earning it the "pharmacy to the world" nickname.

Examples of big brands altering their commercial approach away from the rep-driven model have often involved mature products. Those in the sunset of their patent life provided drugmakers a haven for experimenting with alternative marketing channels: non-personal promotion, sophisticated CRM (customer relationship management)… we're in the middle of significant structural change…Digital transformation can be a key enabler of success in some really challenging and very fiercely competitive markets. But it's going to [require] us to do things very differently...

Safety issues with first female libido pill (Addyi,flibanserin) may spur better alternatives for women...Most women with low sexual desire won't rush to get the first prescription drug to boost female libido when it becomes available…But they may…spur development of better treatments for women's sexual problems after more than a decade of neglect by most of the world's large drugmakers…Treatments for women's libido issues are an untapped financial opportunity for drugmakers. Analysts estimate the market could be worth over $2 billion, based on academic estimates that between 5 million and 9 million U.S. women may suffer from desire disorders.

In a victory for the pharmaceutical industry, a federal judge decided the Health Resources and Services Administration cannot enforce a rule that would allow many so-called safety-net hospitals and clinics to obtain orphan drugs at a discount… The decision caps more than two years of feuding between drug makers and the agency over a federal program known as 340B. This requires drug makers to offer discounts of up to 50 percent on all outpatient drugs to hospitals and clinics that serve indigent populations...

AstraZeneca Plc opened a new $224-million factory in Russia…The move is intended to reinforce the group’s long-term commitment to the country which is one of the drugmaker’s key emerging markets…it…opened a new manufacturing and packaging plant in the Kaluga region southwest of Moscow…largest foreign investment in the construction of a new pharmaceutical facility in the country…the plant to reach full capacity in 2017 and to produce about 40 million packs and 850 million tablets of some 30 medicines every year, which represents more than 60 percent of the medicines the company sells in Russia...

The best-selling brand-name drugs are not necessarily the most-prescribed medications in the United States…IMS Health recently revealed the 50 most-prescribed brand-name drugs and the 50 best-selling brand-name drugs between April 2014 and March 2015…Here are some noteworthy discrepancies between prescription drug sales and prescribing patterns for particular conditions:

1. Hepatitis C
2. Contraceptives
3. Multiple Sclerosis
4. Hypertension
5. HIV
6. Arthritis
7. Chronic Obstructive Pulmonary Disease
8. Cancer

This issue brief provides an overview of the 2016 PDP marketplace, focusing on key changes from 2015…Many will see higher premiums and deductibles…highlights include:

• beneficiaries in each region will have a choice of 26 PDPs, on average,
• average PDP premium…to increase by 13 percent…from $36.68 to $41.46 per month…largest since 2009
• More than one-third of the 11.2 million PDP enrollees who do not receive Low-Income Subsidies would pay premiums of $60 or more per month…
• Nearly 4.4 million of these enrollees not receiving the LIS face a premium increase of at least $10 per month...
• Two-thirds of all PDPs will have deductibles…a higher share than in previous years. A growing share of PDPs will impose the maximum deductible…to $360..the largest increase in the deductible since the start of the program
• Most PDPs charge coinsurance, rather than flat copayments, for non-preferred brand-name and specialty drugs, which could lead to higher out-of-pocket costs for those who use high-cost drugs.
• Nearly all PDPs use tiered pharmacy networks, with lower cost sharing in selected network pharmacies and higher cost sharing in other network pharmacies, a significant increase
• Beneficiaries receiving the LIS will have access to 7 plans for no monthly premium…fewer than in any past year.