Campaigning to deliver new treatments

We find out what happens after the clinical trials, and how our policy and campaigns work helps get treatments to you faster.

We’re funding research that aims to find new and better treatments, faster. But research isn’t the end of the story. Once the clinical trials are finished, there are still more hurdles to making new drugs and treatments available. And this could be slowing down the process of getting treatments to those who need them. That’s why we’re looking for ways to overcome these hurdles — and asking you to help us get new and better treatments to people faster.

What happens after the clinical trial?

Step 1: licencing new treatments

Once a treatment has been through clinical trials, and been shown to be safe and effective, the pharmaceutical or medical device company must get a licence for their product.

While no treatment is completely risk free, a licence indicates all the proper checks have been carried out and the benefits of a medicine are believed to outweigh the risks. Licences are only granted if high standards of safety and quality are met during the whole development and manufacture of a medicine.

After being licenced, a drug or treatment is authorised to treat a particular condition. If the company think their product or device can effectively treat another condition, then they have to go through the licencing process again for that condition.

There are a number of regulatory bodies who can licence medicines for use in different countries including the Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA).

At the moment authorisation of drugs and treatments for use in the UK happens through the MHRA or the EMA. However this could change with Brexit— our Policy and Campaigns Team are keeping an eye on proposals to make sure that people with Parkinson’s don’t lose out on access to new treatments.

Step 2: appearing in the guidelines

After a licence for a new treatment has been granted it does not mean people will have immediate access to the treatment. The next step involves developing guidelines on how best to treat different conditions.

The main guidelines for the UK are developed by the National Institute for Health and Care Excellence (NICE), and were last published in July of this year. NICE gives independent advice to improve health and social care. They play a role in evaluating which treatments are cost effective and should be available on the NHS in England and Wales.

Northern Ireland usually adopt the main principles of NICE guidelines. Scotland have their own clinical standards called the Scottish Intercollegiate Guidelines Network (SIGN).

NICE and SIGN guidelines were developed to get rid of the post code lottery of where drugs, treatments and care are available. They aim to make sure that people have the same access to treatment and care wherever they live.

To advise on how particular conditions should be treated, NICE and SIGN keep abreast of new medications and technology. They evaluate the evidence available on the benefits of new treatments and share their findings in their guidelines. These guidelines also cover how public health and social care services can best provide support.

Once NICE and SIGN issue their guidelines, the hospitals and services that treat people — the care providers — must find the money to make those drugs or treatments available. NICE and SIGN don’t play a role in funding the treatment options in the guidelines.

Step 3: funding approved treatments

This final stage of how new treatments are funded, and made accessible to people with Parkinson’s, varies in different parts of the UK. This means that not every Parkinson’s drug is easily available across the UK.

In England, the decision to make a treatment available through NHS England ultimately rests with local decision makers called clinical commissioning groups (CCGs).

They decide whether the local care providers want, or can afford, to fund new treatments through the NHS. And this means different treatments may be available in different parts of England.

One example of this is Safinamide, as Laura Cockram, Head of Policy and Campaigning, explains:

“Following a clinical trial of Safinamide in Newcastle, the pharmaceutical company applied for a licence for the drug to be used in the UK to treat Parkinson’s.
“Some CCGs are using Safinamide, however patients where the original trial took place currently aren’t able to access the drug as the CCG formulary committee has so far rejected the application for it to be used.”

In Scotland, Wales and Northern Ireland funding decisions are made more centrally:

  • In Scotland, the Scottish Medicines Consortium (SMC) takes guidance from SIGN and carries out an evaluation of the clinical and cost effectiveness of all newly licensed drugs. The SMC then advises on the availability of treatments within NHS Scotland.
  • Decisions about funding treatments though NHS Wales is based on guidance from NICE and appraisals from the All Wales Medicines Strategy Group (AWMSG).
  • In Northern Ireland, the Formulary is the list of approved treatments that Health and Social Care Trusts can prescribe. Current prescribing patterns, the most recent clinical evidence, patient safety and cost effectiveness are considered before a treatment is added to the list.

Tackling the hurdles to delivering new and better treatments

We know that health and care budgets across the UK are going to be tighter in the years ahead. However, we want to ensure all our investment in research leads to people with Parkinson’s getting better treatments, and a cure, faster.

In order to achieve this, we’re developing an active group of people who can add their voices to our campaigns to ensure vital treatments get to people with Parkinson’s when they need it. And we’re asking people from all over the UK to get involved.

What is campaigning?

Campaigning is asking for change — whether that’s vital improvements to health and social care, better transport services in your area or access to a treatment.

Campaigning activities can be anything from sending an email or signing a petition to meeting with your local decision maker to make your case. You really can make a difference as our case study on the Parkinson’s drug Duodopa highlights.

Campaigning works: Duodopa

Duodopa is a vital treatment for controlling the advanced symptoms of Parkinson’s in a small number of people. While it is not appropriate for everyone, it can be a lifeline for a few when all other medications have been exhausted.
In 2014, we became aware that people with Parkinson’s in England weren’t able to easily access Duodopa.
We lobbied NHS England to fund Duodopa, however it was only when we involved our fantastic campaigners, who wrote to their MPs encouraging them to sign an early day motion (like a petition for back bench MPs) and attend a briefing with prominent neurologists that we managed to get NHS England to agree to fund the treatment.
With the treatment now being funded in England, you helped pave the way for the Scottish Medicines Consortium to agree to fund Duodopa in 2016 and Northern Ireland to confirm they would fund it this year. But we’re still not finished — Wales are currently submitting a proposal to fund the drug there.

How can I get involved?

Campaigning with us can really help to make a difference to people living with Parkinson’s. There are loads of ways to get stuck in and get involved:

Contact us with any queries, or to ask how you can get involved in our work, by emailing or calling 020 7963 9349. You can also use these contact details to invite us to attend a local group meeting and explore how we can work together to improve Parkinson’s services in your area.

This blog is not meant as health advice. You should always consult a qualified health professional or specialist before making any changes to your medications or lifestyle. And if you have any concerns about your medication not working, please speak to a specialist.