A comprehensive global strategy is necessarily to fight the ‘silent epidemic’ of hepatitis C, according to a new report from the Economist Intelligence Unit (EIU).

Social and personal barriers to diagnosis and treatment, combined with the extremely destructive nature of the disease, are contributing to high death rates.

The EIU calls for health systems to develop “innovative ways to reach out to patients”, drawing parallels with the early years of the HIV pandemic.

The Silent Pandemic: Tackling Hepatitis C with Policy Innovation was commissioned by Janssen, a leader in the hepatitis C drug market.

HCV, the virus that causes hepatitis C, is thought to affect 150 million people worldwide – most of whom will develop chronic liver disease. Hepatitis C caused 86,000 deaths in the EU in 2002.

The disease can be prevented and effectively treated, but as few as 10% of people with HCV are receiving treatment.

Causes of the high infection and death rates identified by the report include: transmission through medical equipment and transfusions; transmission through intravenous drug use; poor epidemiological data and a low diagnosis rate; and poor medical compliance by intravenous drug users.

“The report highlights that worldwide, despite the significant burden of HCV, governments have failed to get a grip on the scale and impact of the disease,” said Charles Gore, President of The World Hepatitis Alliance. “In both developed and developing countries, the true human and economic cost of HCV will continue to rise unless policy makers confront this urgent public health issue now.”

The EIU recommends a number of strategies: effective disease surveillance, better public awareness, and measures to reduce high-risk behaviour and transmission via healthcare systems.

It also recommends that health systems find “innovative ways to reach out to patients, rather than relying on traditional healthcare structures”.

Gaston Picchio, Global Hepatitis Disease Area Leader at Janssen, commented: “Janssen is committed to working with the HCV community and will continue to engage with healthcare professionals, government officials and patient advocates around the world to support their efforts to reduce the individual and societal burden of this devastating disease.”

Lack of access to specialists is a major factor in the UK’s high lung cancer mortality rates, according to the UK Lung Cancer Coalition.

The coalition, which includes doctors, pharmaceutical companies and patient groups, has produced an “aspirational” guide to delivering lung cancer care.

Late diagnosis, poorly structured care teams and a “nihilistic view” of the patient’s prognosis were also identified as reducing patient survival rates.

The coalition’s Dream MDT report makes 30 recommendations for delivering lung cancer diagnosis, treatment and care through multidisciplinary teams (MDTs).

The report says these recommendations “should challenge lung cancer practice to strive to exceed, rather than simply meet, NICE guidelines”.

The UK has 240 lung cancer MDTs but too few specialists and a culture of low expectation, the coalition argues. Its recommendations include:

• A Lung Cancer Nurse Specialist should play a key role in ensuring optimal care for each patient.

• Transfer of care from secondary to primary care needs to be improved, with the GP informed of the patient’s progress at all stages.

• Each patient should be assigned a specialist lung cancer physician to manage their treatment.

• The MDT should deliver a two-stage process: diagnosis and treatment.

• Patients should know at all times what the next step is in their care pathway.

According to the coalition, about a third of NHS lung cancer patients do not have access to lung cancer specialist nurses or physicians.

By following the recommendations, the NHS could save 10% of the lives currently being lost to lung cancer, the coalition argued.

While smoking cessation programmes have reduced the incidence of lung cancer, prognosis for those diagnosed with the condition is usually poor.

Thomas Szasz, a leading advocate of ‘patient power’ in psychiatry and critic of forced treatment and psychoactive medication, has died aged 92.

The author of The Myth of Mental Illness (1961) had a significant influence on mental health treatment in the UK, where his championing of psychiatric patients’ right to determine their own treatment pathway had many supporters.

While most psychiatrists did not accept his view that mental illness had no physical basis, Szasz was instrumental in developing a more flexible attitude towards diagnosis and treatment.

In addition, his promotion of community-based psychiatric care helped to influence the mental health strategies of recent decades.

Born in Hungary in 1920, Szasz migrated to the US in 1938. From 1956, he lectured in psychiatry at Upstate Medical University in Syracuse, New York.

As a practising psychiatrist, academic lecturer and writer, Szasz showed a lifelong concern with the dignity and freedom of the individual.

Pointing to the use of psychiatry as punishment in totalitarian societies, he argued that using forced treatment to resolve “problems in living” was a violation of patients’ rights.

According to his colleague Mantosh Dewan, Szasz forced the psychiatric profession to confront “the arbitrariness of psychiatric diagnoses” and helped to bring about the “de-institutionalisation” of many patients.

In 2010, Szasz gave a keynote address to the Royal College of Psychiatrists in the UK – but the RCP’s American counterpart had not given him a platform in almost 50 years.

Teva UK has launched the first generic equivalent of Roche’s Xenical (Orlistat). 

Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese or overweight patients.

Kim Innes, Commercial Director at Teva, says the company delighted to launch the generic in the country.

“As the UK's leading supplier of generics, we're pleased not only to have the widest portfolio of our competitors, but also to show that we're well-placed when it comes to innovation and being the first to market,” said the Commercial Director. 

NICE has recommended a further clinical trial to establish how effective MSD’s Daxas (roflumilast) is for adults with severe chronic obstructive pulmonary disease (COPD) in final draft guidance.

Its independent Appraisal Committee concluded further data was required on its clinical and cost effectiveness as an add-on to bronchodilator treatment for people with a history of frequent exacerbations.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, says a new trial “is a good opportunity to gather robust evidence”.

The trial should be designed, NICE advises, to analyse how effective  and cost effective Daxas is as an add-on to triple or dual therapy.

The Committee decided that research should aim to generate data around the benefits of Daxas as an add-on treatment to long-acting muscarinic antagonists (LAMA) plus long-acting beta agonists (LABA) plus inhaled corticosteroids (ICS), known as triple therapy, or LAMA plus LABA for those people who are intolerant to, or decline, ICS.

NICE believes that the medication is most likely to be used in addition to triple therapy. However, there was no direct clinical evidence provided by MSD in this way, and no possible way of NICE knowing whether Daxas is a cost-effective use of NHS resources.

There are currently around a million people with COPD in England and Wales. NICE estimates that nearly 90,000 people would be eligible for the treatment by 2015.

“The Committee noted that, in usual practice, roflumilast was most likely to be used in addition to triple therapy, but there were no directly relevant clinical trial data on this treatment regimen for the Committee to consider,” said Professor Longson.

“There are a lot of people with COPD, and those likely to be treated with roflumilast could receive treatment for a long time. This meant that a high degree of uncertainty about the clinical and cost effectiveness was not acceptable to the Committee.”

If NICE does not receive any appeals to the draft guidance, a final decision will be published in January 2012.

Pharmaceutical companies Lundbeck and Otsuka have formed a global alliance to deliver up to five new psychiatric and neuroscience drugs.

The Danish and Japanese pharma companies, both of which have a strong record in CNS products, have signed a sales and cost share agreement.

The alliance covers two near-term projects from Otsuka and an earlier-stage portfolio of psychiatric disorder treatments, encompassing psychotic, mood and behavioural disorders at all levels of severity, from Lundbeck.

The two companies have identified psychiatric disorders as a major area of unmet need.

Lundbeck is granted co-development and co-commercialisation rights to two Otsuka drugs: aripiprazole depot formulation (which improves compliance in users of the drug) and OPC-34712 (for schizophrenia and major depressive disorder).

Otsuka will have an option to co-develop and co-commercialise up to three early-stage compounds in Lundbeck’s R&D pipeline.

“With the addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with exciting and unique treatments in an area of high unmet needs,” said Ulf Wiinberg, Lundbeck’s President and CEO.

“This collaboration further strengthens our US platform and allows us to be introduced with the US psychiatry community already in 2013."

Dr. Taro Iwamoto, President and Representative Director, Otsuka, commented: “We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialisation agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka’s CNS business.

“Lundbeck’s expertise in developing depression and anxiety treatments and Otsuka’s expertise in developing anti-psychotics will maximise the medical and commercial value of Otsuka’s portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these compounds to patients who need them.”

Through the sales and cost share agreement, Otsuka will receive up to US$1.8 billion from Lundbeck – which will see its psychiatry portfolio and US market penetration increase.

The combination of Otsuka’s strong presence in North America and Asia with Lundbeck’s strong presence in Europe, Canada and Latin America mean that the alliance will reach most of the global psychiatric market.

In Part III of his diary, Omar Ali discusses the significance of process mapping and the wide reaching influence of health technology assessments and regulatory bodies.

1.10pm: GP CONSORTIA/CCG – RESPIRATORY ASTHMA PROCESS MAPPING & FORMULARY

I’m trying to step into the main meeting room but one of the CCG/GPs pulls me aside. It’s a mixture of a low-key signal and a discreet ‘thumbing’ to pull away from the group. He wants a quiet word and it’s clear that there are some key issues, agendas and directions that are on the table for this asthma meeting.

The process mapping event takes some four hours – evaluating everything and anything that ‘leads to an asthma admission’, followed by everything and anything that occurs after the admission and leads to discharge – which is then followed by QIPP ‘bottlenecks’, where re-admissions and inefficiencies occur.

It’s always a challenge having so many viewpoints – nurses, physicians, pharmacists, budget holders, and of course patients and carers who often change the whole paradigm when we hear about their experience, expectations and concerns around ‘choice’.

Thoughts for pharma

Respiratory is big. Whether on prescribing budgets, healthcare priorities, implementation of national guidance or QIPP streamlines. Companies haven’t yet got their act together on process mapping of care pathways, but it’s the only way to invest in prescribing up-front drugs for potential ‘return to the QIPP baseline’ over the next three to five years. Needless to say, whilst the NHS talks QIPP, pharma is getting used to it and patients are still puzzled by it.

Asthma

With so much behind National Guidance/BTS, QoF and commissioning cycles, some companies are indeed getting into the mix with Clinical Commissioning Groups and supporting process mapping. That support is vital, as not only does it bring pharma in as key stakeholders, but more importantly there is a level playing field here in the same room bringing the cause back on track.

So often in the NHS we have silo budgets chasing after silo savings. Process mapping brings us out of our silos into the bigger picture and into the ‘process map’. Seeing it happen is a wonderful thing.

COPD

Given we make such a fuss around the cost of drugs, in truth we know two things: the most expensive drug is the one that is not being taken, and the tariff for an admission for COPD at £3,400 is more expensive than the annual price of the most expensive inhaler!

So where’s the issue? It goes like this. Pharmaceutical companies come to us quoting the costs of admissions in COPD then tell us how amazing it would be to reduce these hospitalisations.

They then tell us how amazing their COPD product is and tell us that we would be crazy to not buy their inhaler, which is a fraction of the cost of COPD burden/admissions. The GPs, nurses and patients love it and want it and state they ‘need it’. Medicines Management then look like the bad guys for not funding the said branded inhaler.

4.15pm: DRIVING BACK TO NHS BASE CAMP – CHECKING VOICEMAILS

One of the big five companies has asked me to come and present to their European heads-of-country on ‘payer issues’ in the UK and the influence of HTAs.

It’s a bit short notice and I gather the VP for Europe, Middle-East and Asia will be there. Times are tough and I see this as an example of how the EU can join forces on some of the key payer issues beginning to filter through.

I have one question back to these pharma companies. What is your data on reducing these expensive hospitalisations in COPD? Because in truth, with the data, I buy the story.

In most cases pharma will then spin another story around how compliance is great, or a patient support programme is excellent. But given all the spin that has come on how much COPD costs me in hospitalisations, it’s a shame many of the companies don’t have the evidence to help me.

They have marketing but not the evidence. Show me the money. And the formulary will be yours.

Thoughts for pharma

There is no doubt that the UK is ‘different’, but I don’t imagine global HQ for any of the pharmaceutical companies readily accepting that – especially when the targets are high and sales may not be so. It sometimes takes global agencies to hear about payer issues ‘from the horse’s mouth’.

This was the quote stated to me regarding this piece of work/event. From my work abroad – at NICE I informally interact with a number of contacts in other countries who belong to their residing equivalents – I can’t stress enough the importance of NICE, the SMC and similar bodies.

The last SMC decision on pain management was quoted verbatim within two weeks by three different countries within the EU. I’m also aware from my US/value-based pricing work that when NICE rules on a drug the impact on the US healthcare system is far reaching.

Insurance companies download the information – they can’t believe NICE do all this work transparently and then leave it freely available for anyone to download – and the US agencies then use this information on deciding what percentage they will ask patients to pay.

So, if NICE say no and SMC say no, somewhere a butterfly flaps its wings and then a patient in the US, who has paid extra funds into a private insurance policy, will be told that this particular brand is not covered and that the patient will have to make an additional payment if they want the drug.

To be continued...

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust and sits on the External Reference Group for Cost Impact Modelling for NICE. He may be reached on omar.ali@sash.nhs.uk.

Generic manufacturer Mylan has agreed a $17.5 million deal with Pfizer for the exclusive rights to develop, manufacture and commercialise a portfolio of respiratory products.

As part of the deal, Mylan will have licensing rights to Pfizer’s generic equivalent to GSK’s Advair and Seretide.

Heather Bresch, Mylan President, says the agreement offers a “significant opportunity for our generics business”.

The agreement will also see Mylan retaining staff at Pfizer’s respiratory inhalation development team at Discovery Park in Sandwich, Kent. Other former Pfizer staff will be located in Cambridge.

Under the terms of the agreement Mylan will have rights to Pfizer’s dry powder inhaler (DPI) technology platform, as well as the opportunity to negotiate on existing compounds during different stages of their development in the Pharma giant’s pipeline.

Mylan will have to pay the costs for any remaining development and commercialisation for the transferred products. Additional payments will also be made once the deal is completed, depending on the regulatory and commercial success of the portfolio.

Advair Diskus and Seretide Diskus are inhaled fixed-dose combinations of Fluticasone Propionate and Salmeterol which are delivered via a DPI and used to treat asthma and COPD.

On completion of the deal, Mylan with gain the exclusive commercialisation rights for Seretide in the US, Canada, Australia and New Zealand, as well as in the EU and European Free Trade Association countries. The two companies will have the co-promotion rights to the product in the rest of the world.

Bristol-Myers Squibb (BMS) has entered into a broad framework agreement with Dako on the development of pharmacodiagnostic tests.

The agreement, which builds on a collaboration begun in 2008, aims to develop diagnostics to identify patients more likely to benefit from treatment with BMS investigational drug candidates.

Pharmacodiagnostics (or companion diagnostics) are an important feature of the growing personalised medicine approach, which can improve outcomes and reduce healthcare costs by identifying individuals who are more likely to benefit from specific therapies.

Dako, a global leader in tissue-based diagnostics, has a history of developing clinical diagnostics in collaboration with pharmaceutical companies that are used in conjunction with drugs.

“It is a great pleasure for me to announce Dako’s new collaboration with Bristol-Myers Squibb,” said Lars Holmkvist, CEO of Dako. “This alliance heralds the intentions of both companies to work closely together to develop new diagnostic tests linked to drugs for the higher purpose of identifying the patients most likely to respond to treatment.”

“It is part of Dako’s long-term strategy to collaborate with pharma companies on the development of companion diagnostic tests.”

Based in Denmark, Dako produces reagents, instruments and software used by hospitals and clinics in more than 80 countries worldwide in the diagnosis of cancer and the planning of its treatment.

Draft NICE guidance does not recommend the routine use of AstraZeneca’s anti-oestrogen drug Faslodex (fulvestrant) in the NHS to treat certain types of breast cancer.

Faslodex was authorised in 2010 for marketing as an alternative to aromatase inhibitors to delay the growth of oestrogen-receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women who have already received anti-oestrogen therapy (such as tamoxifen).

NICE’s Independent Advisory Committee has concluded that the drug is not significantly more effective than existing treatments, and so its routine use would not be a good use of resources.

The Committee judged AstraZeneca’s claim that Faslodex could extend life relative to the aromatase inhibitors anastrozole and letrozole to be uncertain as network meta-analyses showed no statistically significant differences.

In addition, they found that Faslodex delayed cancer growth more effectively than anastrozole but not more so than letrozole. An incremental cost effectiveness ratio of £35,000 per QALY gained for Faslodex 500mg compared with anastrozole was estimated, but with “considerable uncertainty”.

The draft guidance thus recommends that NHS doctors should not prescribe Faslodex as an alternative to aromatase inhibitors in relevant cases – but that women who are currently receiving Faslodex should be able to continue to do so until they and their doctors decide to stop.

Sir Andrew Dillon, Chief Executive of NICE, commented: “While there is evidence that fulvestrant can delay the growth of breast cancer, our independent committee found that when used according to its marketing authorisation, its effectiveness is uncertain compared to aromatase inhibitors, which are currently the preferred treatment options on the NHS.

“As fulvestrant has not been proven to be cost-effective, we cannot justify diverting NHS funds from other areas of healthcare in order to fund its use.”

The draft guidance is open to appeal until 24 November. NICE hopes to publish final guidance in January 2012.