Pharmaceutical companies should collaborate more with patients during early-stage research in order to better meet the needs of its customers, according to a new report.

Research suggests that patient perspectives are increasingly been sought during drug development to help pharma identify and define valuable new medicines.

But further collaboration is needed, the report says, in order to consider the relevance to patients of new products so that clinical trials can be designed appropriately with these points in mind.

Patient Reported Outcomes (PROs) are not a new move by pharmaceutical companies conducting research during drug development.

Pharma has used PROs in cases where appropriate measurements in clinical trials must be developed and validated as part of the drug development process. But complex planning is initially required which often delays the start of research.

PROs are seen as valuable by health regulators with the FDA and EMA working on processes to support such schemes. Reimbursement authorities also use the outcomes to define value.

Organisations are also in place to assist pharmaceutical companies to gather information from patients, carers and clinicians who share interests in a particular disease area. The EU Patient Partnership Project promotes the roles of patient organisations during clinical trials to empower them to interact with key stakeholders during research stages.

But the project has identified barriers between pharma and patient bodies including a lack of expertise and awareness of clinical research by patients and an unwillingness to enter collaboration by pharma over concerns of negative publicity.

The report, Patient Perspectives – Patient Reported Outcomes Drive Drug Development, but Improving Patient Involvement Remains a Challenge, adds that these concerns need to be corrected and that further PRO tests are conducted to ensure that pharma meets the needs of patients, regulators and reimbursement authorities in the future.

As his working day finally comes to an end in part IV of his diary, Omar Ali discusses the new methods pharma needs to use to interact with its customers and how to ensure formulary is gained for its products.

4:15pm: DRIVING BACK TO NHS BASE CAMP – CHECKING VOICEMAILS

Request for appointment in U/C and IBD: An interesting proposition from a company aimed at payers around healthcare costs and the potential for a patient access scheme. They’re looking to set up a ‘payer round-table forum’ for all the hospital pharmacists and some PCT advisors to consider this in terms of the health economy.

Thoughts for pharma

It must be hard to see all the ‘payer’ decision makers – PCT advisers, D&T pharmacists, commissioners, budget holders – in a coordinated fashion so that they can in unison consider your proposal. Bringing together payers in a room for half a day is another way of ‘bringing the mountain to Mohammed’. The new NHS is asking for new ways of working; so why are you guys still calling ‘door-to-door’ to sell double glazing? Get real, bring the decision makers together, get round the table, thrash out the proposal. If
it costs money, then let it cost money.It will save you from wasting it on another munch-bunch GP evening,
booked for 30 people where only eight invitees turn up and listen to a key opinion leader talk about your brand on advertised slides when the PCT has already told them “it’s not on formulary”. Pharma needs to think of the different keys that will unlock the different doors. I am glad to see some companies seeing the light – whilst others have already thought up old school pharma solutions without mapping the problem.

NICE REQUEST FOR A PANEL ON ERG

A call from NICE to sit on another ERG Panel; they’ve also booked a teleconference call to evaluate a new toolkit for NHS healthcare professionals to account for tariffs and internal financial mechanisms within the external/overall healthcare costs.

Thoughts for pharma

This is a long story – please see previous article on tariffs that sometimes reward counter-intuitive funding decisions where issues around tariff, income generation and commissioning get in the way of basic healthcare economies of scale. Last week I was in Scotland and can see that the devolved nations have a far less adversarial approach to implementing new drugs due to the absence of the ‘internal market’ within both of these countries.

GP COMMISSIONER/ EVENING MEETING

A request for me to present on a White Paper to a Primary Care Forum from a CCG in the West Country – topics to include diabetes outcomes.

Thoughts for pharma

I was honoured. This was a direct recommendation from the GP consortia to present at a PCT-wide meeting. I think he feels that the PCT is pushing hard on costs of diabetes drugs, whereas the costs of diabetes complications need factoring. Locally we are having a review with one of the CCG/GP consortia on implementing diabetes prescribing and I sense the GP is torn between good diabetes care and the fact that we can’t afford good diabetes drugs. Around the UK, or certainly England, Peter Rowe/QIPP has caused a stir by recommending a direction back to NPH insulin (v.analogues) and reducing/limiting blood glucose test strips – which we are considering. This led to a frenetic and reactive pharma response, which to my mind needs tempering and rationalising. Again, the argument “What would you want for your
grandma?” doesn’t work. It doesn’t matter what I want for my grandma. That’s not a basis from which to draw up a policy on reimbursement of health economy interventions – it was tried in Oregon and it failed. I foresee difficult times here and tough decisions. I myself wouldn’t have thought we would come to the day when we started switching patients back to NPH, but it has indeed started happening. What this means for companies who i) market insulin analogues and ii) are soon to launch insulin analogues needs careful re-assessment and they need to get their payer story straight first time. It’s clear this decision does not
have the full buy-in from diabetologists and diabetes nurses. But indeed it’s the payers leading on this and the payers that will set the tone of reimbursement. Pharma needs to sort its payer story and it needs QIPP alignment, because at the moment, QIPP alignment means non-alignment with your brand.

CONSULTANT CARDIOLOGIST – REQUEST FOR D&T APPLICATION FORM/ASSISTANCE

A consultant from our Trust is applying for a new product which has just launched. The implications are not short of massive. I have already passed this onto another two directorates for consultation and strategic management. It’s going to be big, and I think this will be more than just ‘another drug’ on the formulary.

Thoughts for pharma

I generally do not see great applications at the D&T. They are usually fair to poor. Despite numerous attempts and repeated communications, consultants don’t turn up. The forms completed by pharma are obviously usually disregarded. Consultants need assistance. I will aim to support/advise, but as I sit on the D&T I am unable to fill in the forms for them. They need to run this from beginning to end. And take
ownership of the drug. Furthermore, in this case, it’s not just cardiology. I think haematology and pathology will need to be involved to the level where they could well be very annoyed at the thought of being bypassed.

4.50pm: ARRIVAL BACK AT NHS BASE CAMP

In the corridor – impromptu discussion with a consultant rheumatologist.

Thoughts for pharma

Touching base on a number of therapeutic issues that are in prescribing format, including the choice of an anti-TNF, a new patient access scheme in place, how we will manage methotrexate injection in the community, navigating a drug we are using which NICE has said ‘no’ to, and finally the closure of the denosumab story – all our PCT acute Trusts are now on-formulary, it took a fair bit of ‘round tables’, crossforum prescribing discussions and a little key I found called HRG  Code X30.9, which has framed this
drug in a whole new way. In fact, once we reviewed the issues, it was simplifying the problem which led us to the collective answer from a commissioning perspective.

Einstein once said, “Everything should be made as simple as possible, but no simpler.” In this case anyway, he was right.

Keep it real. The Matrix.

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.

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.