Falling Generic Drug Prices:

Ontario started it but many other provinces have followed....the mandated drop in generic drug prices covered under the Public Drug Plans.  B.C. is the latest province to mandate a lowering of generic prices.

http://www.theglobeandmail.com/news/national/british-columbia/bc-to-cut-price-of-generic-drugs/article1633666/?cmpid=nl-news1

Canada gets 'D' in innovation :

The Conference Board of Canada has awarded a “D” for innovation for Canada. This places Canada in 14^th place in a list of 17 countries studied. Canada does not successfully commercialize its scientific and technological discoveries into world-leading products and services.

http://www.theglobeandmail.com/report-on-business/canada-gets-d-in-innovation/article1452800/

Orphan Drug Applications Doubled In Past 10 Years :

Pharma appears to be focusing more on research into treatments for rare diseases, according to a survey by Tufts University. The survey suggested that applications for orphan drug approvals doubled during the last decade. The Tufts Center for the Study of Drug Development says the FDA granted orphan drug status to 425 experimental products between 2006 and 2008, up from 208 between 2000 and 2002. The Orphan Drug Act, without question, can be considered a success. It has been emulated throughout the world, and today Japan and Europe have similar programs, while Singapore and Australia give special allowance for the importation and marketing approval of orphan products approved in the U.S." 

http://pharmalive.com/news/index.cfm?articleID=680046&categoryid=9&newsletter=1

Fury over Irish plans for Rx charges:

Irish Health Minister Mary Harney has caused a storm by announcing that the government is considering introducing the nation’s first-ever prescription charges.  The Department of Health and Children is considering charging people with medical cards 50 cents per prescribed item, as a way of saving money and curbing excessive prescription drug use, the Minister has revealed, but opponents of the plan say it would target those least able to pay.

http://www.pharmatimes.com/WorldNews/article.aspx?id=16918&src=EWorldNews

US Approves Healthcare Overhaul:

Democrats in the House of Representatives narrowly passed sweeping health care reform legislation Saturday night, with only one Republican joining in the vote and the minority party nearly unanimous in its opposition.  

The vote passed 220-215 with 39 Democrats voting against the bill, and one Republican supporting the sweeping plan.

http://abcnews.go.com/Politics/nancy-pelosi-democrats-pass-sweeping-health-care-reform/story?id=9027367

Phase 2 of Alberta's Pharmaceutical Strategy:

Phase two of the pharmaceutical strategy will see the Alberta government:

• reduce generic drug prices — Starting immediately, prices for new generic drugs will be reduced from 75 per cent of a brand name drug price to 45 per cent - a reduction of as much as 30 per cent. Prices for existing generic drugs will also be reduced significantly, beginning in April 2010. Over the coming month, government will continue its discussions with pharmacists and pharmacies about this price reduction; more details are expected in December. Reduced prices for generic drugs will be available to all Albertans.  

• provide faster access to new drugs and reduce costs  — Like other provinces, Alberta will negotiate contracts, known as product listing agreements, with brand name drug manufacturers. These contracts reduce costs through volume discounts, provide faster access to new, innovative drugs and help fund health research. Ontario, Quebec, B.C. and Manitoba currently use product listing agreements.

• expand the role of pharmacists to better meet the needs of patients — Government will work closely with Alberta pharmacists and pharmacies to have pharmacists spend more time using their professional knowledge and skills to counsel and advise patients so they get the best results from their medications.  To support this expanded role, government will introduce a new payment model for pharmacies.

CDR Update-Subsequent Entry Biologics:

CDR Update - New Pilot Project: Subsequent Entry Biologics - Submissions for drugs reviewed by Health Canada as subsequent entry biologics (SEBs) should be filed with the Common Drug Review (CDR). Based on its experience reviewing the first SEB submission, CDR has initiated a pilot project. The need for the pilot arises from the fact that SEBs are a new category of Health Canada submissions with different data requirements. The purpose of the pilot process is to determine the CDR requirements for the SEB submissions; establish the evaluative framework for conducting the CDR review; and through interactions with Health Canada, gain an increased understanding of Health Canada’s approach to assessing SEBs.  The pilot project will be evaluated after three SEBs have been reviewed. The findings from the evaluation will assist in identifying the submission requirements for SEBs and will guide the development of an evaluative framework

http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-62

200 Western Drugs for China:

200 western drugs appear on China’s first-ever list of essential medicines, which totals 307 mainly prescription products and will become available at heavily-subsidised prices in stages starting from September 25. The essential drugs list is a central plank of the country’s $124 billion programme of health service reform, which aims to provide affordable health cover for more than 90% for its 1.3 billion population by next year, and the medicines which have been selected for price controls are used in treating up to 80% of China’s most common diseases, according to the government. 

http://www.pharmatimes.com/WorldNews/article.aspx?id=16459&src=EWorldNews

CADTH Issues Important Clarification—Type of Economic Analysis to be Submitted:

Situations where cost tables may be the only economic analysis provided would be when the submitted drug belongs to an established drug class consisting of multiple agents that have a similar mechanism of action and therapeutic use and comparative trials show no difference in safety and efficacy or only placebo-controlled trial evidence is available. In most other situations, the pharmacoeconomic submissions should include a cost-utility analysis or cost-effectiveness analysis. This would include, but is not limited to, submissions for drugs that are new molecules and drugs that have a new (unique) mechanism of action. Revised CDR Submission Guidelines for Manufacturers are scheduled for posting in July 2009 and will include changes to Appendix 15 — Guidelines for the Type of Economic Analysis to be Submitted.

http://www.cadth.ca/index.php/en/cdr/cdr-update/cdr-update-issue-58

Drugmakers reach deal to reduce US Medicare coverage gap:

President Barack Obama’s effort to overhaul the U.S. health system got an $80 billion shot in the arm from drugmakers, through an agreement that will keep the U.S. elderly buying brand-name medications.

http://www.bloomberg.com/apps/news?pid=20601087&sid=a4Dk8.ConNig

National Institue of Health:

Drugs for "neglected" or rare diseases.

The National Institutes of Health is wading into the drug-development process by launching a program aimed at finding and getting new drugs ready for testing in humans with rare diseases.

The development program would also target so-called neglected diseases, while rare in the U.S., are often linked to parasites that sicken millions of people who live in tropical parts of the world.

http://online.wsj.com/article/SB10001424052970203771904574177701770654102.html

PhRMA says it supports comparative effectiveness research:

In the Wall Street Journal (4/6) Health Blog, Shirley S. Wang wrote, "Drug-industry leaders wrapped up the annual meeting of the trade group PhRMA over with weekend with repeated references to 'comparative effectiveness,' a buzz phrase being uttered more and more these days." Notably, "President Obama recently called for $1.1 billion in government funding for such research to determine best practices in medical care, which has been discussed as one way to help rein in costs in the healthcare system." According to David Brennan...chief executive of AstraZeneca who was just elected chairman of the trade group, "The industry is on-board with the concept, and some companies are already doing studies to figure out which drugs lead to the best patient outcomes."

Drug Import Bill Goes to the Senate:

A bipartisan group of senators introduced legislation to import prescription drugs from abroad as part of broader efforts to reduce drug costs in the U.S.  The legislation would allow U.S.-licensed pharmacies and drug wholesalers to import FDA-approved medications from Canada, Europe, Australia, New Zealand and Japan.

http://news.morningstar.com/newsnet/viewnews.aspx?article=/dj/200903041443dowjonesdjonline000888_univ.xml

Pfizer to Disclose Payments to Doctors:

Pfizer said it will begin disclosing all sizable payments it makes to doctors, including those who test experimental drugs in people, a first for the industry. The disclosures would begin early next year and are planned to include all payments to medical personnel who prescribe drugs -- doctors, physician's assistants and nurse-practitioners -- exceeding $500 in a year.

http://www.bloomberg.com/apps/news?pid=20601202&sid=aKGrkkg70UPI

Canadian Pharmaceuticals go to USA - Again?:

The Obama White House is planning to reverse the policy, to let seniors make a choice where to buy their prescription drugs.  Five years ago the FDA shut down the US store selling less expensive Canadian pharmaceuticals.  The FDA said it was because of safety concerns but could not site one case of a senior who had gotten ill from Canadian pharmaceuticals.

http://www.sandiego6.com/news/local/story/Obama-to-Allow-Lower-Prescription-Drugs-from/NMrigBst8Um69t9sxY0BQg.cspx

UK offering free prescriptions to patients with cancer:

As of April 1st up to 150,000 cancer patients in England can start to apply for free prescriptions on the NHS.

http://news.bbc.co.uk/2/hi/health/7838234.stm

FDA Allows Promotion of Unapproved Uses:

US health officials finalized guidelines that make it easier for pharmaceutical companies to tell doctors about unapproved uses of medicines, a practice opposed by critics of industry marketing. The US Food and Drug Administration guidelines explain when manufacturers may distribute copies of medical journal articles that describe unapproved uses. The action could help companies expand the markets for medicines and medical devices.

http://www.reuters.com/article/rbssHealthcareNews/idUSN1233270220090113

Not enough comparative-effectiveness data exists:

When drugs and devices go through the Food and Drug Administration approval process, they're compared with placebos.  Few are tested in head-to-head trials.  "They just have to be better than noghing," said David O. Bardbe, MD, chair of the AMA Council on Medical Services.  However, if some leading politicians and policy experts have theri way, much more comparative-effectiveness research will be generated soon.

The concept of a national comparative-effectveness body has support in the health care, insurance, consumer and public policy world.

For more information on this story go to:

http://www.ama-assn.org/amednews/2008/12/01/gvsa1201.htm

UK government secures pricing deal with pharma:

The government and the drugs industry have struck a deal which could save the NHS in the UK up to £550m  ($523 M) per year.  The deal has been welcomed by the pharmaceutical industry as being simpler than the earlier proposals, and will mean that prices paid by the UK's state health service are cut by 3.9 percent from February next year, and by 1.9 percent more in January 2010. 

http://www.hemscott.com/news/static/tfn/item.do?newsId=70415990648013 

http://news.bbc.co.uk/2/hi/health/7737027.stm

UK to allow "top up" payments:

UK health secretary Alan Johnson on Tuesday overturned a rule banning patients from receiving NHS care if they choose to pay privately for drugs. In addition, the minister announced that a series of measures will be implemented to "substantially widen access" to treatments covered by the NHS.

More drugs are to be made available to patients on the NHS, particularly for those facing a terminal illness, Health Secretary Alan Johnson announced.

http://nds.coi.gov.uk/environment/fullDetail.asp?ReleaseID=383246&NewsAreaID=2&NavigatedFromDepartment=False

Northern Ireland to abolish prescription charges:

           Northern Ireland is to abolish prescription charges completely by April 2010, subject to approval by the Stormont Executive cabinet. In an interim stage, the charge will be reduced from £7 to £3 per prescription from next January, and the cost of prepayment certificates will be cut from £35.85 for four months and from £98.70 to £25 from next April for a year until they are free. Cost of free prescriptions could be found within the existing budget and without impacting on any existing service. The Minister also said he would be encouraging health care professionals to “prescribe sensibly.”  Prescription charges in Wales have already been abolished, and the Scottish Assembly has pledged to follow suit by 2011. Last week’s announcement by Prime Minister Gordon Brown that England would scrap the charge for cancer patients and eventually, for all people with long-term conditions, led to calls for Northern Ireland’s leaders to act speedily on the recommendations of the review. 

http://www.pharmatimes.com/UKNews/article.aspx?id=14435&src=EUKNews

UK announces free prescriptions for cancer patients:

The UK government on Tuesday announced that patients with cancer will not have to pay NHS charges for prescription medication in England as of April 2009. British Prime Minister Gordon Brown also indicated that the eventual goal is to eliminate prescription charges for all patients with long-term conditions.

The cost of the prescriptions is expected to be covered by savings generated through increased bulk purchasing of medications and greater use of generic treatments. Brown commented that "as the NHS generates cash savings in its drugs budget, we will plough them back into abolishing charges for all patients with long-term conditions."

Under the new plan, which will cost an estimated 20 million pounds ($37 million) over the next year, about 250 000 people will be exempted from NHS prescription charges. Once other long-term conditions are added, the number of eligible patients could increase to five million and the cost could climb to 300 million pounds ($557 million) per year.

The move follows an initiative by the Scottish government to phase out prescription charges by 2011. Meanwhile, in Wales, such fees have already been abolished.

Scottishe initiatives:  http://www.firstwordplus.com/Fws.do?articleid=A562ED3D940742BDBA348942BA0E3689

Fees abolished in Wales:   http://www.firstwordplus.com/Fws.do?articleid=6778DD254D9346BF97960E0FF529A4D4

Scotland “risks two-tier pharma care” :

There “may be a case” for allowing cancer patients to top-up their National Health Service (NHS) treatment with privately-purchased care, Scottish government ministers have said.  Decision-making in relation to a patient who believes they can enhance their health through additional treatment which they exercise a choice to purchase should be seen as part of a…framework of assessment of risk and clinical benefit.  a leading cancer charity has warned that any move towards a co-payments system in Scotland, “however, well-intentioned,” will have a negative effect on patients.  Bowel Cancer UK spokesman Ian Beaumont believes that such a move will act as a disincentive for the Scottish Medicines Consortium (SMC) to approve new cancer treatments and for NHS Boards to make them available, on the grounds that patients can get them privately. “In turn, this will further discriminate against those people who are least able to pay for treatments and against exceptional cases, thus adding to the inequities that this inquiry sought to address. 

http://www.pharmatimes.com/UKNews/article.aspx?id=14291&src=EUKNews

Postal Code Lottery in the UK:

UK patient’s “end of the road” court bid for Revlimid - A terminally-ill cancer patient has gone to the UK High Court to challenge the decision by his Primary Care Trust not to fund treatment for him with Celgene’s Revlimid (lenalidomide). If he lived a mile and a half in either direction from where he does, the PCTs covering these areas would have supplied the drug. This is the “end of the road” for Mr Ross unless he gets the drug, Mr Clayton told the court; he is no longer on any life-extending treatment, but treatment with Revlimid, if successful, could extend his life by three years. Without it, he will die within the next three months.  

http://www.pharmatimes.com/UKNews/article.aspx?id=14279&src=EUKNews

PMPRB Requires Reporting of Payments to 3rd Parties:

PMPRB released its decision on the reporting of payments to 3rd parties.  The question to be considered was "should certain benefits (compassionate free goods, trial prescription: expenditure limitation agreements) be excluded from the determination of an average transaction price?

The Board decsions was that mandatory reporting of these benefits begin for the January to June 2009 period.  The Board views consistent and complete reporting as essential to a fair and transparent mandate to ensure accuracy in pharmaceutical pricing.  The calculation of the average price must include all of the following that are linked to "sales":

• Rebates/Discounts
• Free goods and/or free services
• Gifts and/or other benefits

For a copy of the complete report follow the link below

http://www.pmprb-cepmb.gc.ca/CMFiles/Notice&Comments-E42IYW-8202008-196.pdf