Drop in US pharma sales calls

Monday, August 23rd, 2010

The number of sales calls made by the pharma industry to US health professionals dropped in the first half of 2010.

Overall, in the US, sales calls to practitioners decreased 1% in the first half of 2010 compared with the previous 6 months, according to a study by healthcare market insight and analytics firm SDI.

The study also found that sales rep calls and details accounted for 36% of the industry’s investment during the first four months of 2010, making it the second most common form of promotion after drug sampling.

Pfizer, Merck (MSD in the UK), and GlaxoSmithKline, which made the most sales calls in the first six months of 2010, each registered declines from the second half of 2009. Pfizer sales calls decreased 2%, while Merck and GlaxoSmithKline experienced larger declines at 16% and 7%, respectively.

In contrast, calls made by Novartis sales representatives actually increased 7%. Valturna, a product that combines the active ingredients in Diovan and Tekturna, and was approved by FDA to treat hypertension in December 2009, was the subject of 19% these calls.

“With the number of pharmaceutical sales reps being scaled back dramatically over the last few years, it’s no surprise that sales calls across the industry are also declining,” said Jason Fox, Associate Director of Syndicated Analytics at SDI.

“However, companies with new drugs or newly approved indications for existing drugs need to get the information into the hands of physicians and other practitioners, and in-person calls are still the most popular type of promotion, outside of product sampling.”

SDI provides patient-level data to pharmaceutical, biotech, retail pharmacy, and medical device companies, enabling them to better understand the healthcare market.

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US GSK rep bonuses to be decided by customers

Tuesday, July 27th, 2010

Customer feedback will play a central role in deciding the bonuses that sales representatives working at GSK’s US subsidiary will receive, as part of a new scheme to be implemented from 2011 onwards.

The company is implementing a compensation system that will rely on the customer service provided by the sales professional, as well as adherence to the company’s values of transparency, integrity, respect and patient-focus.

It is part of a wider effort on the part of GSK to better target its sales staff based on the changing needs of healthcare professionals (HCPs).

“The US healthcare marketplace is changing significantly in response to demand by patients, healthcare providers and payers for higher quality care, lower costs and better health outcomes,” said Deirdre Connelly, President of North America Pharmaceuticals at GSK.

“Physicians have been telling us they want to see fewer sales professionals, and those they do see need to provide greater value in helping improve patient health. In response, we are changing the way we sell our medicines and vaccines in order to deliver the value our customers demand, in a transparent way, with integrity and respect for the patient,” she added.

GSK is hoping to align its sales efforts with the needs of US HCPs working in large health systems or integrated delivery networks where decisions on purchasing are made from a central office.

“We’ve spent a good deal of time listening to our customers, and they are asking us for more information about reimbursement, disease education and support for improving patient health,” Deirdre Connelly concluded.

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European pharma braced for prize squeeze

Friday, July 23rd, 2010

Pharma companies are bracing themselves for further reductions on drug prices across Europe.

CEOs fear the austerity measures being introduced by governments across the region are likely to lead to increased pressure for lower-priced medicines.

Andrew Witty, GSK CEO, expects price pressure to accelerate through the second half of the year and become a ‘2011 phenomenon’.

Europe accounted for 30.6 per cent of global drug sales in 2009, according to IMS Health. But industry bosses are concerned about the future of the market, with some of the leading players predicting a downturn.

Johnson & Johnson has said that cost containment efforts in Europe could have $200 million impact on its business in 2010, while Novartis claims that drug price cuts have already driven a 3% decline in its sales during the first half of the year.

GSK’s Witty anticipates a similar decline. “We see Europe as being roughly a minus 3 (per cent annually) type of marketplace on an ongoing basis. It is likely that over the next 18 months we will see something a little more than 3. Whether it is going to be a lot more than 3 is still a little premature to call,” he said.

Dominic Caruso, CFO at J&J, says that although pricing pressures are not unusual, they are having a growing impact on the European market: “We have experienced pricing pressure year-over-year (in Europe) in any event, so it is not an unusual phenomenon, but there is now incremental pricing pressure,” he said. “I would say that the incremental pricing pressure on an annual basis looks like it is in the mid-single digits impact to the European businesses."

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GSK launches new renal cancer drug

Monday, July 5th, 2010

A new first-line treatment for advanced renal cell carcinoma (RCC) has been launched in Europe following a conditional EMA approval.

GlaxoSmithKline’s Votrient (pazopanib) is now available for the first-line treatment of patients with advanced RCC and for patients who have previously received cytokine therapy for advanced disease.

The conditional approval was based on results from a phase III trial, which showed that Votrient reduced the risk of progression in these patients by 54% compared with placebo, providing up to five extra months’ progression-free survival (PFS).

Votrient is a selective tyrosine kinase inhibitor (TKI) that has a specific kinase affinity profile.

Professor Robert Hawkins, Consultant Medical Oncologist at The Christie, Manchester, has welcomed the new licence: “The introduction of targeted therapies such as TKIs has greatly improved outcomes for many patients with renal cancer.

“Currently used TKIs can produce ongoing side effects as such mucositis and stomatitis which have a profound effect on how patients are able to function day to day. Votrient provides clinicians with a welcome alternative option that may not present the same adverse event burden.”

Advanced RCC is one of the most treatment resistant cancers – around nine out of ten patients die within five years.

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Further indication for Tyverb approved

Tuesday, June 29th, 2010

The EMA has granted a new indication for GSK’s oral breast cancer treatment Tyverb (lapatinib).

Approval was given for Tyverb, in combination with an aromatase inhibitor (AI), to treat post-menopausal women with hormone receptor (HR)-positive, ErbB2 (HER2) over-expressing metastatic breast cancer, based on evidence that it can increase progression-free survival (PFS) by more than five months in this indication.

Professor of Breast Cancer Medicine, Stephen Johnston, Royal Marsden NHS Foundation Trust & Institute of Cancer Research, commented: “Lapatinib plus an AI offers an effective, chemotherapy-free and well-tolerated option for patients with a distinct disease profile. As a first line option for these patients it offers a choice to delay the need for more aggressive and toxic therapies, such as chemotherapy. Importantly as an all-oral treatment option it allows patients to take their medication at home, relieving precious hospital resources.”

As an oral treatment, Tyverb has the potential to relieve hospital resources, but also to allow patients more time at home with their families.

Around 50% of patients with ErbB2-positive metastatic breast cancer are also HR-positive. A phase III trial in over 1200 patients demonstrated that ErbB2-positive patients given lapatinib plus letrozole experienced a median 8.2 months of PFS, compared with 3 months without lapatinib.

Lapatinib is already indicated (in combination with Xeloda/capecitebine) for patients with ErbB2-positive metastatic breast cancer, pretreated with anthracyclines and taxanes, who have progressed following treatment with trastuzumab in the metastatic setting. NICE, however, recently ruled that the drug is not a cost-effective use of NHS resources in this indication.

Tyverb in combination with letrozole is currently being considered by the NICE work programme as part of a Multiple Technology Appraisal (MTA) – guidance is expected in the first half of 2011.

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Not enough evidence to recommend Arzerra

Thursday, June 24th, 2010

NICE says it has not recommended a new treatment for leukaemia because there is no evidence comparing it with current NHS treatment.

The draft guidance for GSK’s Arzerra (ofatumumab), for the treatment of chronic lymphocytic leukaemia that is refractory to the drugs fludarabine and alemtuzumab, stated that the drug did not represent good value for money, even though GSK had offered it at a discounted price.

The independent appraisal committee concluded that the data provided by GSK were not robust enough to demonstrate how well the drug improves overall survival rates compared to the currently available best supportive care (regular outpatient appointments, blood transfusions and bone marrow transplants as necessary).

Sir Andrew Dillon, NICE Chief Executive, said: “We can only recommend drugs where the evidence shows them to work better than current NHS treatments, and when they represent good value for money for the NHS. In this case, the manufacturer’s evidence included interim results from a clinical trial where all patients received the ofatumumab and which is not scheduled to report its full findings until next year.

“The lack of hard evidence on disease-free and overall survival rates has also been acknowledged by the UK’s Medicines and Healthcare products Regulatory Agency and also the Food and Drug Administration in the USA. They have both granted a conditional licence for the drug on the proviso that more research must be carried out to prove its clinical benefit.”

The preliminary guidance is now available for public consultation until 19 July 2010.

Final guidance is expected later this year.

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Stakeholders ‘disappointed’ by Tyverb guidance

Thursday, June 10th, 2010

Tyverb (lapatinib) will not be recommended for use on the NHS for breast cancer, following draft guidance that the drug does not provide sufficient clinical benefit to justify its high cost.

The GSK drug was assessed in combination with capecitabine (Xeloda) for women with advanced or metastatic HER2-positive breast cancer, but it was ruled that it should only be used in the context of clinical trials.

A NICE committee of hospital doctors, GPs, nurses, and patients examined whether Tyverb would be an effective life-extending treatment option for women who have already been treated for advanced or metastatic, HER2-positive breast cancer.

Despite consideration of NICE’s policy towards end-of-life treatments and GSK’s offer to pay for the cost of lapatinib for the first 12 weeks, it was decided that Tyverb did not represent good value for money when compared with current treatments.

Sir Andrew Dillon, NICE Chief Executive, said: “This has been a long and comprehensive evaluation of the evidence available but only because we want to be sure the decision reached is the right one and made for the right reasons.

“We are disappointed not to be able to recommend lapatinib but evidence suggests it only extends life by a small amount of time – around 10 weeks (2.4 months) – and costs thousands of pounds more than one of the more commonly used NHS treatments for this indication – capecitabine on its own.”

GSK has also expressed its frustration, pointing out that there are no other licensed ErbB2 targeted treatment options available to suppress the advanced disease and that many receive Herceptin (trastuzumab) off-licence.

Simon Jose, General Manager, GSK UK, said: “GSK has worked really hard to offer the best possible value to the NHS, which makes this decision particularly disappointing. It again highlights the limitations of the NICE appraisal process when evaluating cancer treatments for patients facing a relatively short life expectancy.

“There are 39 NHS Trusts across the UK that have signed up with GSK for the patient access scheme, reflecting the clinical demand for Tyverb and recognising its potential value to the NHS, and more importantly to patients.”

The company has announced that it will continue to make its patient access scheme available to trusts, as well as continuing an ongoing clinical trials programme that will evaluate lapatinib both alone and in combination with other therapies.

Commenting on the draft guidance, Maggie Alexander, Director of Policy, Education and Influencing at Breakthrough Breast Cancer, said: “It is crucial to remember that this drug would not be suitable for all, and patients should speak to their doctor regarding appropriate treatments available to them. We will continue to work with NICE in the future to ensure that patients with advanced or metastatic breast cancer have the best possible range of treatment options for their condition.”

Consultees have until 24 June 2010 to appeal against this final draft of the guidance. Until final guidance is published, NHS bodies are encouraged to make funding decisions locally.

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Revolade rejected for ITP

Thursday, June 10th, 2010

NICE has ruled that there is insufficient evidence to recommend GSK’s Revolade (eltrombopag) for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Preliminary guidance states that the drug is not recommended for ITP in splenectomised adults who do not respond to other treatments (for example, corticosteroids, immunoglobulins), or as second-line treatment for non-splenectomised adults when surgery is not advised.

The independent Appraisal Committee considered the use of eltrombopag in patients who do and do not have persistent bleeding problems. They concluded that, although eltrombopag can raise platelet levels, the evidence was very unclear about how many health benefits the drug would provide compared with other existing treatments.

The cost of eltrombopag in relation to the estimated health benefits was also considered far greater than what is normally judged a cost-effective use of NHS resources.

Gillian Leng, Deputy Chief Executive of NICE, said: “The Appraisal Committee understood that for people living with ITP, the risk of bleeding can have a considerable effect on their daily activities and also prevent or delay surgery. But unfortunately, the committee felt there was not sufficient evidence to recommend eltrombopag as a treatment for ITP.”

Interested parties now have the opportunity to comment on the draft recommendations.

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